0001140361-23-014526 | 10-K | XBRL Viewer

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SIGNIFICANT ACCOUNTING POLICIES, Goodwill (Details) $ in Millions	12 Months Ended
	Dec. 31, 2022 USD ($) Segment Unit	Dec. 31, 2021 USD ($)
SIGNIFICANT ACCOUNTING POLICIES [Abstract]
Number of operating segment \| Segment	1
Number of reporting units \| Unit	1
Impairment of intangible assets and goodwill \| $	$ 3.0	$ 2.6

INVENTORIES

12 Months Ended

Dec. 31, 2022

INVENTORIES [Abstract]

INVENTORIES

NOTE 3 — INVENTORIES:

Net inventories consist of the following at December 31:

	December 31
	2022		2021
Raw Materials	$	4,539,346	$	7,306,095
Work in Process		1,106,962		3,556,878
Finished Goods		2,069,105		2,057,478
	$	7,715,413	$	12,920,451

During the year ended December 31, 2022 and 2021, the Company recognized inventory adjustments related to expired and obsolete items totaling $0.6 million and $4.1 million respectively.

LONG-TERM DEBT, Credit Agreement (Details) - Senior Secured Term Loan Credit Facility [Member] - USD ($)		12 Months Ended
	Sep. 03, 2019	Dec. 31, 2022
Credit Agreement [Abstract]
Debt instrument, face amount	$ 20,000,000
Lender's closing cost	550,000
Financing fee	$ 600,000
Percentage of gross proceeds considered as financing fee	3.00%
Interest rate	8.75%	12.88%
Increase in interest rate in event of default	4.00%
Principal installment payable	$ 300,000
Debt instrument maturity date		Sep. 03, 2023
Outstanding loan balance, net		$ 18,600,000
LIBOR [Member]
Credit Agreement [Abstract]
Term of variable rate		1 month
Basis spread on variable rate	2.50%

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2022	Mar. 24, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Annual Report	true
Document Period End Date	Dec. 31, 2022
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Document Transition Report	false
Entity File Number	001-35569
Entity Registrant Name	CHEMBIO DIAGNOSTICS, INC.
Entity Central Index Key	0001092662
Entity Incorporation, State or Country Code	NV
Entity Tax Identification Number	88-0425691
Entity Address, Address Line One	3661 Horseblock Rd
Entity Address, City or Town	Medford
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	11763
City Area Code	631
Local Phone Number	924-1135
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	CEMI
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	true
Entity Shell Company	false
Entity Public Float			$ 18,739,117
Entity Common Stock, Shares Outstanding		36,725,858
Auditor Firm ID	42
Auditor Name	Ernst & Young LLP
Auditor Location	Jericho, New York

REVENUE

12 Months Ended

Dec. 31, 2022

REVENUE [Abstract]

REVENUE

NOTE 6 — REVENUE:

Disaggregation of Revenue

Exchange transactions are recognized in accordance with ASC Topic 606, Revenue from Contracts with Customers, while non-exchange transactions are recognized in accordance with ASU 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and Accounting Guidance for Contributions Received and Contributions Made.

The following tables disaggregates total revenues for the period ending December 31, 2022:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	47,091,673	$	-	$	47,091,673
R&D revenue		112,986		-		112,986
Government grant income		-		1,182,023		1,182,023
License and royalty revenue		1,135,241		-		1,135,241
	$	48,339,900	$	1,182,023	$	49,521,923

The following tables disaggregates total revenues for the period ending December 31, 2022 by region:

	Total
Africa	$	7,000,085
Asia		665,159
Europe & Middle East		4,518,475
Latin America		19,265,840
United States		18,072,364
	$	49,521,923

The following tables disaggregates total revenues for the period ending December 31, 2021:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	34,737,444	$	-	$	34,737,444
R&D revenue		1,159,381		-		1,159,381
Government grant income		-		10,891,726		10,891,726
License and royalty revenue		1,029,901		-		1,029,901
	$	36,926,726	$	10,891,726	$	47,818,452

The following tables disaggregates total revenues for the period ending December 31, 2021 by region:

	Total
Africa	$	5,562,788
Asia		664,579
Europe & Middle East		5,179,267
Latin America		18,418,983
United States		17,992,835
	$	47,818,452

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

+ Details

GOODWILL AND INTANGIBLE ASSETS (Details) - USD ($)	12 Months Ended
GOODWILL AND INTANGIBLE ASSETS (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Goodwill [Roll Forward]
Goodwill, Beginning balance	$ 3,022,787
Changes in foreign currency exchange rate	10,778
Impairment	(3,033,565)	$ (2,600,000)
Goodwill, Ending balance	0	3,022,787
Intangible assets [Abstract]
Cost	0	4,946,421
Accumulated Amortization	0	1,896,290
Impairment	0	3,050,131
Net Book Value	0	0
Amortization Expense [Abstract]
Amortization expense	0	479,988
Impairment of Intangible Assets [Abstract]
Impairment of intangible assets		3,100,000
Intellectual Property [Member]
Intangible assets [Abstract]
Cost	0	1,636,724
Accumulated Amortization	0	546,252
Impairment	0	1,090,472
Net Book Value	$ 0	0
Amortization Expense [Abstract]
Amortization period	10 years
Developed Technology [Member]
Intangible assets [Abstract]
Cost	$ 0	1,944,500
Accumulated Amortization	0	828,681
Impairment	0	1,115,819
Net Book Value	$ 0	0
Amortization Expense [Abstract]
Amortization period	7 years
Customer Contracts / Relationships [Member]
Intangible assets [Abstract]
Cost	$ 0	1,254,344
Accumulated Amortization	0	477,661
Impairment	0	776,683
Net Book Value	$ 0	0
Amortization Expense [Abstract]
Amortization period	10 years
Trade Name [Member]
Intangible assets [Abstract]
Cost	$ 0	110,853
Accumulated Amortization	0	43,696
Impairment	0	67,157
Net Book Value	$ 0	$ 0
Amortization Expense [Abstract]
Amortization period	11 years

GOODWILL AND INTANGIBLE ASSETS

12 Months Ended

Dec. 31, 2022

GOODWILL AND INTANGIBLE ASSETS [Abstract]

GOODWILL AND INTANGIBLE ASSETS

NOTE 8 — GOODWILL AND INTANGIBLE ASSETS:

Following is a table that reflects changes in Goodwill:

Beginning balance January 1, 2022	$	3,022,787
Changes in foreign currency exchange rate		10,778
Impairment		(3,033,565	)
Balance at December 31, 2022	$	—

During the Company’s interim goodwill impairment testing conducted during the first quarter of 2022, it was concluded that goodwill was impaired and an impairment of $3.0 million was recognized during the period ended December 31, 2022. During the period ended December 31, 2021, $2.6 million was recognized as an impairment.

Intangible assets consist of the following at:

			December 31, 2022								December 31, 2021
	Weighted Average Remaining Life		Cost		Accumulated Amortization		Impairment		Net Book Value		Cost		Accumulated Amortization		Impairment		Net Book Value
Intellectual property		-	$	-	$	-	$	-	$	-	$	1,636,724	$	546,252		1,090,472	$	-
Developed technology		-		-		-		-		-		1,944,500		828,681		1,115,819		-
Customer contracts/relationships		-		-		-		-		-		1,254,344		477,661		776,683		-
Trade names		-		-		-		-		-		110,853		43,696		67,157		-
			$	-	$	-	$	-	$	-	$	4,946,421	$	1,896,290		3,050,131	$	-

Intellectual property, developed technology, customer contracts/relationships and trade names were being amortized over 10, 7, 10 and 11 years, respectively. Amortization expense for the year ended December 31, 2022 and 2021 was $0 and $479,988, respectively.

As of December 31, 2021, the Company recognized an impairment loss of all its finite-lived intangible assets totaling $3.1 million. As of December 31, 2022, no additional finite-lived intangible assets remained.

SIGNIFICANT ACCOUNTING POLICIES, Fixed Assets (Details)	12 Months Ended
SIGNIFICANT ACCOUNTING POLICIES, Fixed Assets (Details)	Dec. 31, 2022
Minimum [Member]
Fixed Assets [Abstract]
Estimated useful lives of fixed assets	3 years
Maximum [Member]
Fixed Assets [Abstract]
Estimated useful lives of fixed assets	7 years

DESCRIPTION OF BUSINESS

12 Months Ended

Dec. 31, 2022

DESCRIPTION OF BUSINESS [Abstract]

DESCRIPTION OF BUSINESS

NOTE 1 — DESCRIPTION OF BUSINESS:

Chembio Diagnostics, Inc. (“Chembio”) and its subsidiaries (collectively with Chembio, the “Company”) develop and commercialize point-of-care tests used to detect and diagnose infectious diseases, including sexually transmitted disease, insect vector and tropical disease, COVID-19 and other viral and bacterial infections, enabling expedited treatment.

The Company’s product portfolio is based upon our proprietary DPP technology, a diagnostic platform that provides high-quality, cost-effective results in 15 to 20 minutes using fingertip blood, nasal swabs and other sample types. The DPP technology platform addresses the rapid diagnostic test market, which includes infectious diseases such as sexually transmitted infections and HIV, and Women’s Health. Compared with traditional lateral flow technology, the DPP technology platform can provide:

•	Enhanced sensitivity and specificity: This is achieved via the Company’s proprietary approach to separating the sample path from the buffer path, together with patent and other proprietary strategies, which differ significantly from traditional lateral flow test.

•	Advanced multiplexing capabilities: Through advanced multiplexing, the DPP platform can detect and differentiate up to eight distinct test results from a single patient sample, which can deliver greater clinical value than other rapid tests currently on the market.

•

Objective results: For some diagnostic applications, the Company’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzers can report accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on site. Objective results produced by the DPP Micro Reader can reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.

The Company targets the market for rapid diagnostic test solutions for infectious diseases, which is driven by the high prevalence of infectious diseases globally, an increase in the geriatric population, growing demand for rapid test results, and advancements in multiplexing. The Company has a broad portfolio of infectious disease products, which prior to 2020 were focused principally on sexually transmitted disease and fever and tropical disease. In February 2020 the Company began the process to leverage the DPP technology platform to address the acute and escalating need for diagnostic testing. The Company is continuing to pursue or has pursued:

•	a 510(k) clearance from the U. S. Food and Drug Administration (the “FDA”) for the DPP SARS-CoV-2 Antigen test system;

•	an Emergency Use Authorization from the FDA for the DPP Respiratory Antigen Panel; and

•	a Clinical Laboratory Improvement Amendment (“CLIA”), waiver from the FDA for the DPP HIV-Syphilis test system, which was approved in February 2023.

LONG-TERM DEBT	12 Months Ended
LONG-TERM DEBT	Dec. 31, 2022
LONG-TERM DEBT [Abstract]
LONG-TERM DEBT	NOTE 13 — LONG-TERM DEBT: On September 3, 2019, the Company entered into a Credit Agreement and Guaranty (the “Credit Agreement”) with Perceptive Credit Holdings II, LP (the “Lender”). The Credit Agreement provides for a $20,000,000 senior secured term loan credit facility, which was drawn in full on September 4, 2019. Under the terms of the Credit Agreement, the Company may use the proceeds (i) for general working capital purposes and other permitted corporate purposes, (ii) to refinance certain of the Company’s existing indebtedness and (iii) to pay fees, costs and expenses incurred in connection with the Credit Agreement, including the Lender’s closing cost amount of $550,000, which was netted from the proceeds, and a financing fee of $600,000 (3.0% of gross proceeds) payable to Craig-Hallum Capital Group LLC, the Company’s financial advisor for the financing. Principal outstanding under the Credit Agreement bears interest at a rate per annum equal to the sum of (a) the greater of the one-month London Interbank Offered Rate and 2.5% plus (b) 8.75%. At any time at which an event of default has occurred and is continuing, the interest rate will increase by 4.0%. Accrued interest is payable on a monthly basis. On December 31, 2022 the interest rate was 12.88%. No principal repayments were due under the Credit Agreement prior to September 30, 2022. Chembio did not elect to prepay principal and an event of default identified in the Credit Agreement did not occur that would have accelerated principal payments. Principal installments in the amount of $300,000 are payable on the last day of each of the eleven months from September 2022 through July 2023, and all remaining principal is payable at maturity on September 3, 2023. Chembio’s obligations under the Credit Agreement are secured by a first priority, perfected lien on substantially all of its property and assets, including its equity interests in subsidiaries. As of December 31, 2022, the loan balance, net of unamortized discounts and debt issuance costs, was $18.6 million, and Chembio was in compliance with its loan covenants.

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
CURRENT ASSETS:
Accounts receivable, allowance for doubtful accounts	$ 346,896	$ 243,042
STOCKHOLDERS' EQUITY:
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	36,765,785	30,104,986
Common stock shares outstanding (in shares)	36,765,785	30,104,986
Treasury stock, shares (in shares)	48,057	48,057

EQUITY INCENTIVE PLANS, Allocated Share-based Compensation Expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	$ 2,299,081	$ 2,034,247
Cost of Product Sales [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	209,792	174,537
Research and Development Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	446,769	494,235
Selling, General and Administrative Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense	$ 1,642,520	$ 1,365,475

SIGNIFICANT ACCOUNTING POLICIES, Fair Value of Financial Instruments (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 18,178,985	$ 28,772,892
Level 2 [Member]
Fair Value of Financial Instruments [Abstract]
Fair value of total debt	19,100,000	20,000,000
Carrying value	18,600,000	18,800,000
Money Market Funds [Member] \| Level 1 [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 18,200,000	$ 28,800,000

- Definition

Amount, excluding unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

REVENUE (Tables)

12 Months Ended

Dec. 31, 2022

REVENUE [Abstract]

Disaggregation of Revenue

The following tables disaggregates total revenues for the period ending December 31, 2022:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	47,091,673	$	-	$	47,091,673
R&D revenue		112,986		-		112,986
Government grant income		-		1,182,023		1,182,023
License and royalty revenue		1,135,241		-		1,135,241
	$	48,339,900	$	1,182,023	$	49,521,923

The following tables disaggregates total revenues for the period ending December 31, 2022 by region:

	Total
Africa	$	7,000,085
Asia		665,159
Europe & Middle East		4,518,475
Latin America		19,265,840
United States		18,072,364
	$	49,521,923

The following tables disaggregates total revenues for the period ending December 31, 2021:

	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	34,737,444	$	-	$	34,737,444
R&D revenue		1,159,381		-		1,159,381
Government grant income		-		10,891,726		10,891,726
License and royalty revenue		1,029,901		-		1,029,901
	$	36,926,726	$	10,891,726	$	47,818,452

The following tables disaggregates total revenues for the period ending December 31, 2021 by region:

	Total
Africa	$	5,562,788
Asia		664,579
Europe & Middle East		5,179,267
Latin America		18,418,983
United States		17,992,835
	$	47,818,452

COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS, Nasdaq Communications (Details) - $ / shares	12 Months Ended
	Dec. 31, 2022	Apr. 05, 2022
Nasdaq Communications [Abstract]
Minimum bid price requirement, price per share for listing (in dollars per share)		$ 1
Minimum bid price requirement, threshold consecutive business days	10 days
Minimum bid price requirement, threshold consecutive business days to regain compliance	180 days

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS, Employee Litigation (Details)				12 Months Ended
	Mar. 08, 2023 Letter	Mar. 19, 2021 Claim	Jan. 03, 2020 USD ($) shares	Dec. 31, 2022 USD ($) Claim
Employee Litigation [Abstract]
Number of filed complaints \| Claim		15
Exercise price of stock options			$ 943,126
Vested shares exercisable (in shares) \| shares			266,666
Term to exercise stock options				30 days
Number of complaint purport to allege claims for breach of each of separate stock option agreements \| Claim				10
Prejudgment interest rate				9.00%
Subsequent Event [Member]
Merger Litigation [Abstract]
Number of demand letters rceived \| Letter	13
Minimum [Member]
Employee Litigation [Abstract]
Loss contingency, asserting damages amount				$ 3,190,198
Loss contingency, asserting damages excess amount				3,000,000
Loss contingency, claims entitlement to recover damages amount				$ 10,000,000

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	Common Stock [Member]	Additional Paid-in-Capital [Member]	Treasury Stock [Member]	Accumulated Deficit [Member]	AOCL [Member]	Total
Balance at Dec. 31, 2020	$ 202,235	$ 124,961,514	$ (190,093)	$ (97,106,331)	$ (90,916)	$ 27,776,409
Balance (in shares) at Dec. 31, 2020	20,223,498		(41,141)
Common Stock:
Issuance of stock, net	$ 97,093	38,714,865	$ 0	0	0	38,811,958
Issuance of stock, net (in shares)	9,709,328		0
Restricted stock issued	$ 1,359	105,582	$ 0	0	0	106,941
Restricted stock issued (in shares)	135,908		0
Restricted stock compensation, net	$ 0	1,160,953	$ 0	0	0	1,160,953
Restricted stock compensation, net (in shares)	0		0
Shares tendered for withholding taxes	$ 0	(145,225)	$ 0	0	0	(145,225)
Shares tendered for withholding taxes (in shares)	0		0
Options:
Exercised	$ 363	85,192	$ 0	0	0	85,555
Exercised (in shares)	36,252		0
Stock option compensation	$ 0	873,294	$ 0	0	0	873,294
Treasury stock	0	16,461	$ (16,461)	0	0	0
Treasury stock (in shares)			(6,916)
Warrants exercised	$ 0	0	$ 0	0	0	0
Warrants exercised (in shares)	0		0
Comprehensive loss	$ 0	0	$ 0	0	(501,456)	(501,456)
Net loss	0	0	0	(33,903,529)	0	(33,903,529)
Balance at Dec. 31, 2021	$ 301,050	165,772,636	$ (206,554)	(131,009,860)	(592,372)	34,264,900
Balance (in shares) at Dec. 31, 2021	30,104,986		(48,057)
Common Stock:
Issuance of stock, net	$ 64,662	4,246,824	$ 0	0	0	4,311,486
Issuance of stock, net (in shares)	6,466,191		0
Restricted stock issued	$ 1,946	264,141	$ 0	0	0	266,087
Restricted stock issued (in shares)	194,608		0
Restricted stock compensation, net	$ 0	967,262	$ 0	0	0	967,262
Restricted stock compensation, net (in shares)	0		0
Shares tendered for withholding taxes	$ 0	(41,537)	$ 0	0	0	(41,537)
Shares tendered for withholding taxes (in shares)	0		0
Options:
Exercised	$ 0	0	$ 0	0	0	0
Exercised (in shares)	0		0
Stock option compensation	$ 0	1,065,731	$ 0	0	0	1,065,731
Treasury stock	0	0	$ 0	0	0	0
Treasury stock (in shares)			0
Comprehensive loss	0	0	$ 0	0	255,085	255,085
Net loss	0	0	0	(23,290,657)	0	(23,290,657)
Balance at Dec. 31, 2022	$ 367,658	$ 172,275,057	$ (206,554)	$ (154,300,517)	$ (337,287)	$ 17,798,357
Balance (in shares) at Dec. 31, 2022	36,765,785		(48,057)

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS, Benefit Plan (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Benefit Plan [Abstract]
Percentage of employer's matching contribution	40.00%
Employee contribution subject to employer matching contribution	5.00%
Employer matching contribution	2.00%
Expenses related to matching contribution	$ 191,113	$ 138,513

REVENUE (Details) - USD ($)	12 Months Ended
REVENUE (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Disaggregation of Revenue [Abstract]
Product sales	$ 49,521,923	$ 47,818,452
Africa [Member]
Disaggregation of Revenue [Abstract]
Product sales	7,000,085	5,562,788
Asia [Member]
Disaggregation of Revenue [Abstract]
Product sales	665,159	664,579
Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Product sales	4,518,475	5,179,267
Latin America [Member]
Disaggregation of Revenue [Abstract]
Product sales	19,265,840	18,418,983
United States [Member]
Disaggregation of Revenue [Abstract]
Product sales	18,072,364	17,992,835
Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	48,339,900	36,926,726
Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	1,182,023	10,891,726
Net Product Sales [Member]
Disaggregation of Revenue [Abstract]
Product sales	47,091,673	34,737,444
Net Product Sales [Member] \| Africa [Member]
Disaggregation of Revenue [Abstract]
Product sales	7,000,085	5,562,787
Net Product Sales [Member] \| Asia [Member]
Disaggregation of Revenue [Abstract]
Product sales	626,210	664,579
Net Product Sales [Member] \| Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Product sales	3,351,003	4,067,682
Net Product Sales [Member] \| Latin America [Member]
Disaggregation of Revenue [Abstract]
Product sales	19,253,504	18,418,983
Net Product Sales [Member] \| United States [Member]
Disaggregation of Revenue [Abstract]
Product sales	16,860,871	6,023,413
Net Product Sales [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	47,091,673	34,737,444
Net Product Sales [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	0	0
R&D and Grant Revenue [Member]
Disaggregation of Revenue [Abstract]
Product sales	112,986	1,159,381
R&D and Grant Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	112,986	1,159,381
R&D and Grant Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	0	0
Government Grant Income [Member]
Disaggregation of Revenue [Abstract]
Product sales	1,182,023	10,891,726
Government Grant Income [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	0	0
Government Grant Income [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	1,182,023	10,891,726
License and Royalty Revenue [Member]
Disaggregation of Revenue [Abstract]
Product sales	1,135,241	1,029,901
License and Royalty Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	1,135,241	1,029,901
License and Royalty Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Product sales	$ 0	$ 0

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS

12 Months Ended

Dec. 31, 2022

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract]

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS

NOTE 12 — COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS:

Employment Contracts:

The Company has contracts with three key employees. The following table is a schedule of future minimum salary commitments:

2023		$	1,178,000
2024			383,000

Benefit Plan:

The Company has a 401(k) plan established for its employees whereby it matches 40% of the first 5% (or 2% of salary) that an employee contributes to the plan. Matching contribution expenses totaled $191,113 and $138,513 for the years ended December 31, 2022 and 2021, respectively.

Leases:

The Company leases facilities in New York, Germany, Malaysia, and Brazil, and certain equipment.

The Company’s facility leases generally include optional renewal periods. Upon entering into a new facility lease, the Company evaluates the leasehold improvements and regulatory requirements related to its operations in that location. To the extent that the initial lease term of the related facility lease is less than the useful life of the leasehold improvements and potential regulatory costs associated with moving the facility, the Company concludes that it is reasonably certain that a renewal option will be exercised, and thus that renewal period is included in the lease term and the related payments are reflected in the right-of-use asset and lease liability.

The Company’s leases generally include fixed rental payments with defined annual increases. While certain of the Company’s leases are gross leases, the majority of the Company’s leases are net leases in which the Company makes separate payments to the lessor based on the lessor’s property and casualty insurance costs, the property taxes assessed on the property, and a portion of the common area maintenance where applicable. The Company has elected the practical expedient not to separate lease and nonlease components for all of the Company’s facility leases.

The components of lease expense were as follows:

	Year Ended December 31, 2022		Year Ended December 31, 2021
Operating lease expense	$	1,630,609	$	1,625,280

Finance lease cost
Amortization of right-of-use assets	$	71,129	$	66,872
Interest on lease liabilities		17,015		20,077
Total finance lease expense	$	88,144	$	86,949

Supplemental cash flow and other information related to leases were as follows:

	Year Ended December 31, 2022		Year Ended December 31, 2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	1,453,778	$	1,404,532
Operating cash flows for finance leases		17,015		20,077
Financing cash flows for finance leases		70,514		61,867
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	717,956	$	-
Finance leases		16,234		25,609

Supplemental balance sheet information related to leases was as follows:

	December 31, 2022			December 31, 2021
Finance Leases
Finance lease right of use asset	$	356,997		$	340,762
Accumulated depreciation		(220,021	)		(148,892	)
Finance lease right of use asset, net	$	136,976		$	191,870

Current portion of finance lease liability		76,869			68,176
Finance lease liability, net of current		76,705			139,678
Total finance lease liabilities	$	153,574		$	207,854

Weighted Average Remaining Lease Term
Operating leases	6.6 years			7.5 years
Finance leases	2.1 years			2.9 years

Weighted Average Discount Rate
Operating leases		8.70	%		8.08	%
Finance leases		9.18	%		8.76	%

Maturities of lease liabilities as of December 31 were as follows:

	December 31, 2022						December 31, 2021
	Operating Leases			Finance Leases			Operating Leases			Finance Leases
2023	$	1,428,821		$	87,884		$	1,447,249		$	83,624
2024		1,220,150			60,116			1,221,017			83,624
2025		1,049,442			16,731			1,018,875			55,856
2026		1,080,925			5,940			1,049,442			12,471
2027		1,113,353			355			1,080,925			1,680
Thereafter		2,530,168			-			3,643,520			-
Total lease payments	$	8,422,859		$	171,026		$	9,461,028		$	237,255
Less: imputed interest		(2,081,972	)		(17,452	)		(2,598,583	)		(29,401	)
Total	$	6,340,887		$	153,574		$	6,862,445		$	207,854

Economic Dependency:

The following table discloses product sales the Company had to customers that purchased in excess of 10% of the Company’s net product sales for the periods indicated:

	For The Years Ended										Accounts Receivable
	December 31, 2022					December 31, 2021					December 31, 2022		December 31, 2021
	Net Product Sales		% of Net Product Sales			Net Product Sales		% of Net Product Sales
Customer 1	$	18,050,287		38	%	$	17,576,641		51	%	$	1,630,007	$	7,672,845
Customer 2		7,562,481		16	%		*		*			2,062,431		*
Customer 3		*		*			3,606,552		10	%		*		1,433,305.00

Revenue includes product sales only, while accounts receivable reflects the total due from the customer, including freight.

The following table discloses purchases the Company made from vendors in excess of 10% of the Company’s net purchases for the periods indicated:

	For The Years Ended										Accounts Payable
	December 31, 2022					December 31, 2021					December 31, 2022		December 31, 2021
	Purchases		% of Purc.			Purchases		% of Purc.
Vendor 1	$	5,359,388		34	%	$	*		*		$	381,923	$	–
Vendor 2	$	*		*		$	3,163,285		16	%	$	*	$	1,361,383
Vendor 3	$	2,231,580		14	%	$	2,031,795		10	%	$	179,482	$	353,097

In the tables above, an asterisk (*) indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, did not exceed 10% for the period indicated.

The Company purchases materials pursuant to intellectual property rights agreements that are important components in its products. Management believes that other suppliers could provide similar materials on comparable terms. A change in suppliers, however, could cause a delay in manufacturing and a possible loss of sales, which could adversely affect operating results.

Litigation:

SEC Investigation

The SEC recently concluded an investigation (the “SEC Investigation”) relating to the public offering of common stock that Chembio completed in May 2020 (the “May 2020 Offering”) and to the FDA’s revocation in June 2020 of an emergency use authorization for the DPP COVID-19 IgM/IgG system that was issued by the FDA in April 2020. Chembio received subpoenas from the SEC in July 2020 and April 2021 seeking the production of documents in connection with this investigation. In addition, the SEC delivered subpoenas in April 2021 to five of Chembio’s employees (including its three executive officers, who consist of its Chief Executive Officer and President, its former Executive Vice President and Chief Financial Officer, and its Executive Vice President and Chief Scientific and Technology Officer). An additional subpoena was issued in June 2021 to Chembio’s former Interim Chief Executive Officer and Executive Chair. Each subpoena requested the production of documents relating to the same matters as are the subject of the subpoenas Chembio received. One current employee, the Chief Executive Officer, also received a testimonial subpoena from the SEC.

On March 2, 2023, the Company and the SEC settled the SEC Investigation through an Administrative Order dated March 2, 2023, instituting cease-and-desist proceedings pursuant to Section 8A of the U.S. Securities Act of 1933, as amended. The Company agreed to cease and desist from committing or causing any violations or future violations of Sections 17(a)(2) and 17(a)(3) of the Securities Act and pay a one-time civil monetary penalty of $500,000. Under the terms of the settlement, the Company neither admitted nor denied the SEC’s findings.

Legal Proceedings

Stockholder Litigation

Putative Stockholder Securities Class-Action Litigation

In 2020 four purported securities class-action lawsuits were filed in the United States District Court for the Eastern District of New York by alleged stockholders of Chembio:

•

Sergey Chernysh v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 18, 2020;

•

James Gowen v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 22, 2020;

•

Anthony Bailey v. Chembio Diagnostics, Inc. Richard J. Eberly, Gail S. Page, and Neil A. Goldman, filed on July 3, 2020; and

•

Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P., and Special Situations Private Equity Fund, L.P. v. Chembio Diagnostics, Inc., Richard Eberly, Gail S. Page, Robert W. Baird & Co. Inc. and Dougherty & Company LLC, filed August 17, 2020.

The plaintiffs in each of the above cases alleged claims under Section 10(b) of the Securities Exchange Act of 1934 (the “Exchange Act”), Rule 10b-5 thereunder and Section 20(a) of the Exchange Act. Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P. and Special Situations Private Equity Fund, L.P. (collectively, the “Special Situations Funds”) also asserted claims under Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 (the “Securities Act”) relating to the May 2020 Offering.

On December 29, 2020, the Court issued an Order consolidating the cases and appointing the Special Situations Funds and Municipal Employees’ Retirement System of Michigan (together, the “Lead Plaintiffs”), as co-lead plaintiffs and their respective counsel as co-lead counsel. The consolidated cases are now pending under the caption “In re Chembio Diagnostics, Inc. Securities Litigation.”

The Lead Plaintiffs filed their Consolidated Amended Complaint (the “CAC”) on February 12, 2021. In summary, the CAC purported to allege claims based on assertedly false and misleading statements and omissions concerning the performance of the DPP COVID-19 IgM/IgG System, as well as an asserted failure to timely disclose that the emergency use authorization that had been granted by the FDA with respect to the DPP COVID-19 IgM/IgG System “was - or was at an increased risk of - being revoked.” The CAC named as defendants Chembio, Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan, John Potthoff (together, the “Chembio Defendants”) and the underwriters for the May 2020 Offering, Robert W. Baird & Co., Inc. and Dougherty & Company LLC (the “Underwriter Defendants”).

The CAC purported to assert five counts under the Securities Act and the Exchange Act. Counts I through III were brought under the Securities Act, allegedly on behalf of a purported class consisting of all persons who purchased Chembio common stock directly in or traceable to the May 2020 Offering pursuant to Chembio’s shelf registration statement on Form S 3 (File No. 333-227398) and the related prospectus, as supplemented by a prospectus supplement dated May 7, 2020 (the “Securities Act Class”). Count I purported to allege a claim for violation of Section 11 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count II purported to allege a claim for violation of Section 12 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count III purported to allege a claim under Section 15 of the Securities Act against Ms. Davis, Dr. Polan, Dr. Potthoff, Ms. Page and Mr. Goldman.

Counts IV and V alleged claims under the Exchange Act on behalf of a purported class consisting of all persons who purchased Chembio common stock on the open market from March 12, 2020 through June 16, 2020 (the “Exchange Act Class”). Count IV purported to allege a claim for violation of Section 10(b) of the Exchange Act and Rule 10b-5 thereunder against Chembio, Mr. Eberly, Ms. Page, Mr. Goldman and Mr. Esfandiari. Count V purported to allege a claim under Section 20(a) of the Exchange Act against Mr. Eberly, Ms. Page, Mr. Goldman and Mr. Esfandiari.

Defendants filed a motion to dismiss the CAC on March 26, 2021. The Court issued its Opinion and Order (the “February 23 Order”) on the defendants’ motions to dismiss on February 23, 2022. In its February 23 Order, the Court: (i) dismissed Counts I and II without prejudice as to all defendants named in those Counts except the Underwriter Defendants as to which Counts I and II were not dismissed; (ii) dismissed Count III without prejudice as to all defendants named in that Count; and (iii) dismissed Counts IV and V with prejudice as to all defendants named in those Counts.

On March 9, 2022, Lead Plaintiffs filed a motion for partial reconsideration of the Court’s February 23 Order, which the Court denied on July 21, 2022.On July 14, 2022, all parties in the In re Chembio Diagnostics, Inc. Securities Litigation action participated in a mediation. The mediation was adjourned without an agreement to resolve the action, but the parties continued to discuss a potential negotiated resolution with the mediator’s assistance.

Lead Plaintiffs filed their Second Consolidated Amended Complaint (the “SCAC”) on July 26, 2022. The SCAC purports to allege three counts under the Securities Act on behalf of the Securities Act Class. Count I purports to allege a claim for violation of Section 11 of the Securities Act against Chembio, Ms. Page, Mr. Goldman, Ms. Davis, Dr. Polan, Dr. Potthoff and the Underwriter Defendants. Count II purports to allege a claim for violation of Section 12 of the Securities Act against Chembio, Ms. Page, and the Underwriter Defendants. Count III purports to allege a claim under Section 15 of the Securities Act against Ms. Page, Mr. Goldman, Ms. Davis, Dr. Polan and Dr. Potthoff.

On August 26, 2022, the Company and the other parties to the litigation reached an agreement in principle on the financial terms of a proposed settlement of all claims that were asserted, or could have been asserted, on an individual and class-wide basis against all defendants in the case, including under both the Securities Act and the Securities Exchange Act.

On December 28, 2022, plaintiffs filed a motion for preliminary approval of the class action settlement that included a stipulation of settlement. On February 3, 2023, the Court entered an opinion and order granting preliminary approval of the proposed settlement. The court set a hearing on June 5, 2023 to determine, inter alia, whether final approval should be given to the settlement. The principal terms of the settlement are:

•

A cash payment to a settlement escrow account in the amount of $8,100,000 of which approximately $209,000 is payable by the Company and the remainder is payable by certain of the Company’s insurers;

•

The net proceeds of the settlement escrow, after deduction of Court-approved administrative costs and Court-approved attorneys’ fees and costs, will be distributed to the class; and

•

A release of claims (including unknown claims) and dismissal of the action with prejudice.

By entering into the settlement, the settling parties have resolved the class claims to their mutual satisfaction. However, the final determination is subject to approval by the Court.

Putative Stockholder Derivative Litigation

On September 11, 2020, a putative stockholder derivative action captioned Karen Wong, derivatively on behalf of Chembio Diagnostics, Inc., Plaintiff v. Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan and John G. Potthoff, Defendants, and Chembio Diagnostics, Inc., Nominal Defendant (the “Wong complaint”) was filed purportedly on Chembio’s behalf in the United States District Court for the Eastern District of New York. The Wong complaint purports to assert a claim for violation of Section 14(a) of the Exchange Act and Rule 14a-9 thereunder based on ostensibly false and misleading statements and omissions concerning, inter alia, the Company’s rapid COVID-19 antibody test in the proxy statement disseminated in advance of Chembio’s Annual Meeting of Stockholders held on July 28, 2020. The Wong complaint also asserts claims against the individual defendants for purported breaches of fiduciary duties owed to Chembio, as well as unjust enrichment.

The Wong complaint requests a declaration that the individual defendants have breached or aided and abetted the breach of their fiduciary duties to Chembio, an award of damages to Chembio, restitution, and an award of the plaintiff’s costs and disbursements in the action, including reasonable attorneys’ and experts’ fees, costs and expenses, and improvements to Chembio’s corporate governance and internal procedures regarding compliance with laws.

On March 31, 2022, a second putative stockholder derivative action captioned Michelle Chen, derivatively on behalf of Chembio Diagnostics, Inc., Plaintiff v. Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan and John G. Potthoff, Defendants, and Chembio Diagnostics, Inc., Nominal Defendant (the “Chen complaint”) was filed purportedly on behalf of Chembio in the Supreme Court for the State of New York, County of Suffolk. The Chen complaint purports to assert a claim for breach of fiduciary duty against the defendants based on ostensibly false and misleading statements and omissions, interalia, concerning the Company’s rapid COVID-19 antibody test. The Chen complaint goes on to allege that the misconduct asserted in the complaint gave rise to the filing of the consolidated securities litigation described above.

The plaintiffs in the Wong and Chen actions took part in the July 14, 2022 mediation described above, and the parties subsequently reached an agreement in principle on the terms of a proposed settlement of both actions, subject to execution of settlement papers and court approval. The proposed settlement contemplated the adoption of certain corporate governance measures that did not have to be implemented in the event of a change of control and did not entail any monetary compensation or payment other than the derivative plaintiffs’ attorneys’ fees, which the parties agreed would not exceed $595,000, and subject to Court approval.

On December 5, 2022, the parties to the Wong action advised the court that the parties had reached a settlement in principle of the claims in the Wong action as well as in the related Chen action and requested that the court stay the Wong action to allow the parties sufficient time to finish negotiating the settlement documentation and obtain settlement approval from the state court in the Chen action. The court granted the parties’ request that same day.

On January 31, 2023, the Company announced that it entered into a definitive merger agreement with Biosynex SA.

On February 3, 2023, the Company submitted a letter to the United States District Court for the Eastern District of New York before which the Wong complaint is pending, informing the court of the proposed merger with Biosynex. In its letter, the Company advised the court that because the corporate governance enhancements central to the parties’ settlement in principle will be mooted if the merger is consummated (in which case there will no longer be any Chembio public stockholders), the Company requested that the action should continue to be stayed until such time as it is known whether the merger with Biosynex is completed.

On February 6, 2023, counsel for the plaintiff in the Chen action sent a letter to K&L Gates, as counsel for the defendants, informing them of their intent to request the state court to lift the stay of the Chen action on an expedited basis for the purposes of allowing the plaintiff to engage in limited discovery, and suggesting that the parties speak to the mediator who had previously served the parties.

On February 7, 2023, K&L Gates sent counsel for the plaintiff in the Chen action a letter rejecting their request for discovery but agreeing to engage in a call with the mediator to further discuss the impact of the proposed Merger on the derivative litigation.

On February 13, 2023, the parties in the derivative litigation participated in a call with the mediator to discuss the impact of the proposed Merger on the settlement in principle and plaintiffs’ standing in the event the Merger is consummated, as well as the discovery sought in the Chen action. While no resolution was reached on these issues during the call, the parties agreed to discuss the substance of their call and the mediator’s suggestions with their clients, and counsel for Chen indicated that they would review the Schedule 14D-9, which we filed with the Securities and Exchange Commission on February 14, 2023 in connection with the Offer (as amended and supplemented, the “Schedule 14D-9”) once filed to determine whether they would pursue the discovery for the Chen action set forth in their February 6 letter.

Pursuant to the court’s February 11, 2023 order, the parties to the Wong action filed a joint status letter on February 17, 2023. In that joint status letter, the defendants advised the court that in the parties’ February 13, 2023 call with the mediator, the parties discussed the impact of the Company’s proposed merger with Parent on the settlement in principle of the litigation and on the plaintiffs’ standing to pursue that litigation in the event the Merger is consummated, as well as the proposed discovery sought by counsel for plaintiff in the Chen action. The defendants also advised the court that no resolution of the issues was reached during the call with the mediator, but that counsel for the parties agreed to discuss the substance of the call and the mediator’s suggestions with their clients, and that plaintiff’s counsel in the Chen action had indicated that they would review the Schedule 14D-9 to determine whether they would pursue discovery in that litigation. Defendants also advised the court that defendants’ position continues to be that the putative derivative litigation should be stayed until at least such time as it is known whether the Merger will be consummated and, in the event plaintiff in the Wong action intends to seek to lift the stay in that action, requested that the court schedule a conference to discuss any such request and, if appropriate, to discuss a briefing schedule on any motion to dismiss the case. Defendants also pointed out that the Company had made public disclosure of its consideration of strategic alternatives in its Form 10-Q filed on August 5, 2022, prior to the parties’ entry into their memorandum of understanding dated August 15, 2022, and that the Schedule 14D-9 described in detail the timing of the Company’s discussions with Parent regarding the particular transaction that is the subject of the Merger Agreement. Plaintiff Wong’s counsel stated that Wong would like to pursue discovery from defendants to address plaintiff’s asserted concerns regarding whether defendants intended to proceed with finalizing the settlement agreement over the past months and whether defendants had been planning the Merger for a long while. Plaintiff further asserted that defendants had received the benefit of a stay of proceedings in order to document a settlement, but were now continuing to seek a stay to see whether the Merger closes, resulting in Plaintiff’s loss of standing to pursue the derivative claims. Plaintiff also contended that no stay was currently in place in the case, and requested that the court order defendants to respond to the complaint no later than March 10, 2023. Plaintiff further reserved her rights regarding any obligations that defendants may have pursuant to the memorandum of understanding executed on August 15, 2022.

On February 19, 2023, the court in the Wong action entered an order setting a status conference on March 2, 2023, directing the parties to be prepared to discuss the issues set forth in the joint status letter and whether the stay of the action should be continued. During the March 2, 2023 status conference, the parties advised the court of the status of settlement in light of the proposed Merger and took opposing positions regarding the appropriateness of the stay. The court directed the parties to submit, on or before March 8, 2023, simultaneous letter briefings as to whether the stay should remain in place.

On February 20, 2023, counsel for the plaintiff in the Chen case sent a letter to K&L Gates indicating that they had reviewed the Schedule 14D-9 and remained of the view that the Company is obligated to execute a settlement agreement in the case. Counsel for Chen also indicated that they were willing to continue discussions with the mediator in an attempt to reach an amicable resolution.

On March 8, 2023, the parties to the Wong action filed letter briefs addressing whether the December 5, 2022 stay of the Wong action should remain in place. On March 13, 2023, the court entered an order lifting the stay in the Wong action, directing the parties to meet, confer and submit a proposed discovery schedule to the court on or before March 20, 2023, and requiring that the defendants answer, move or otherwise respond to the complaint in the Wong action on or before April 13, 2023.

On March 17, 2023, the defendants in the Wong action filed a letter with the court advising the court that they intend to move to dismiss the complaint and requesting that the court stay discovery pursuant to the Private Securities Litigation Reform Act (“PSLRA”) pending a ruling on their anticipated motion to dismiss. Defendants further argued that discovery requested by plaintiff regarding the Merger and the defendants’ intent during settlement discussions is not relevant to any claims at issue in the case, and requested that the court adjourn the deadline to submit a discovery plan until after the motion to dismiss is decided. In response, plaintiff submitted a letter to the court in which she argued that the statutory stay does not apply to the discovery being sought or was waived. Plaintiff also submitted a proposed discovery plan for the court’s consideration. On March 18, 2023, the court entered an order denying the defendants’ request to adjourn the deadline to submit a proposed discovery plan and entered its own order requiring fact depositions to be completed on or before August 15, 2023. The court further noted that it will consider whether the statutory stay under the PSLRA applies at the time defendants file their motion to dismiss.

Merger Litigation

On February 17, 2023, a complaint was filed in the United States District Court, Southern District of New York, against the Company and the individual members of the Company Board and management, captioned Sholom Keller v. Chembio Diagnostics, Inc., Katherine L. Davis, John G. Potthoff, David W.K. Acheson, David W. Bespalko, Richard L. Eberly, Leslie Teso-Lichtman, and Lawrence J. Steenvoorden, Case No. 1:23-cv-01388 (the “New York Complaint”).

On March 8, 2023, a pro se complaint was filed in the United States District Court, District of Nevada, against the Company and the individual members of the Company Board and management, captioned David S. Gross v. Chembio Diagnostics, Inc., Katherine L. Davis, John G. Potthoff, David W.K. Acheson, David W. Bespalko, Richard L. Eberly, Leslie Teso-Lichtman, and Lawrence J. Steenvoorden, Case No. 3:23-cv-00093 (the “Nevada Complaint, and together with the New York Complaint, the “Complaints”).

The Complaints asserts that the defendants violated Sections 14(d), 14(e), and 20(a) of the Exchange Act and certain rules and regulations promulgated thereunder by allegedly making false and misleading statements, or failing to disclose allegedly material facts necessary to make the statements made not misleading, relating to the Merger in the Company’s Recommendation / Solicitation Statement on Schedule 14D-9 filed with the SEC on February 14, 2023 (as amended, the “Schedule 14D-9), including allegations relating to the background of the Merger, financial projections, and analyses of the Company’s financial adviser, Craig-Hallum.

In addition to the Complaints referenced above, thirteen demand letters have been received from purported stockholders of the Company as of the date of this Annual Report, each challenging certain of the disclosures in the Schedule 14D-9. Additional complaints may be filed and/or demand letters may be received in connection with the Merger and the Transactions. If additional similar complaints are filed and/or demand letters received, absent new or different allegations that are material, the Company will not necessarily announce such additional complaints or demand letters.

The Company believes that the disclosures set forth in the Schedule 14D-9 comply fully with applicable laws and denies the allegations in the matters described above. However, in order to moot certain of the disclosure claims and avoid the costs, risks and uncertainties inherent in litigation, and provide additional information to its stockholders, the Company determined to voluntarily provide certain additional disclosures reflected in Amendment No. 1 to the Schedule 14D-9. Nothing in these supplemental disclosures, which also include certain supplemental disclosures unrelated to the New York Complaint and/or the demand letters, should be regarded as an indication that the Company or the Company’s affiliates, management, directors or other representatives, or any recipient of this information, considered or now considers the information contained in the supplemental disclosures to be material; rather, the Company believes that the Schedule 14D-9 as filed on February 14, 2023 disclosed all necessary information and denies that any additional disclosures are or were required under any federal or state law.

Employee Litigation

On March 19, 2021, John J. Sperzel III, Chembio’s former chief executive officer, filed a fifteen-count complaint in the United States District Court for the Eastern District of New York. The complaint was filed following the dismissal of an action previously filed by Mr. Sperzel in the United States District Court in Maine, which was dismissed for lack of personal jurisdiction over Chembio. In summary, the complaint filed in the Eastern District of New York alleges that Chembio wrongfully refused to allow Mr. Sperzel to exercise certain options to purchase, for an aggregate exercise price of $943,126, a total of 266,666 shares of common stock that were allegedly vested as of the date of his separation from Chembio, on January 3, 2020. The complaint alleges that under the terms of the applicable stock incentive plans, Mr. Sperzel had thirty days after the date on which he ceased to qualify as an “Eligible Person” under the plans within which to exercise the options, and asserts that by reason of his alleged continued service to Chembio, he remained an “Eligible Person” and ostensibly retained the right to exercise the options. The Compensation Committee of the Board determined that the options expired on February 3, 2020, thirty days after Mr. Sperzel’s separation from Chembio, and that a purported attempt by Mr. Sperzel to exercise the options after that date was not valid.

Count I of the complaint purports to allege that Chembio breached Mr. Sperzel’s separation agreement by refusing to allow him to exercise the stock options. Counts II through XI of the complaint purport to allege claims for breach of each of ten separate stock option agreements, collectively asserting damages of “at least” $3,190,198. Count XII of the complaint alleges a breach of Mr. Sperzel’s separation agreement based on Chembio’s purported failure to pay Mr. Sperzel consulting fees to which he claims to be entitled for consulting services allegedly performed following his separation. Count XIII of the complaint alleges a claim for breach of an implied covenant of good faith and fair dealing under Nevada common law based on the allegation that Chembio prevented Mr. Sperzel from obtaining the benefits of the stock option agreements and separation agreement. Mr. Sperzel alleges that he suffered damages in excess of $3 million as a result of the purported breach of the covenant of good faith and fair dealing. Count XIV of the complaint purports to assert a claim for quantum meruit, alleging that “it is reasonable for Sperzel to expect payment in exchange for ... services” he allegedly provided to Chembio and, based on allegations that upon his separation Mr. Sperzel was not informed as to the pending expiration of the stock options he later sought to exercise, that Chembio has been unjustly enriched. Finally, Count XV of the complaint seeks a declaratory judgment that Mr. Sperzel is relieved from performance under his separation agreement due to asserted material breaches of the agreement based on the allegations summarized above. The complaint seeks compensatory damages in an unspecified amount, a declaration, as described above, and an award of Mr. Sperzel’s costs and expenses in the litigation, including reasonable attorneys’ fees, expert costs and disbursements. The complaint requests a trial by jury. In his initial disclosures served in discovery, Mr. Sperzel claims entitlement to recover damages in a total amount not less than $10 million, together with prejudgment interest at the rate of 9% per annum.

On May 20, 2021, Chembio filed its answer and affirmative defenses denying the material allegations of Mr. Sperzel’s complaint. All discovery in the case was completed in June 2022. On July 6, 2022, pursuant to local court rules, Chembio filed a formal notice with the District Court stating its intention to file a motion for summary judgment on all of Mr. Sperzel’s claims, along with a statement of facts in support thereof. Mr. Sperzel’s filed a responsive letter and factual statements on July 27, 2022, and Chembio filed a timely reply on August 10, 2022. On August 16, 2022, the Court held a pre-motion status conference, during which the Court directed the parties to confer regarding the renewal of settlement discussions. The parties subsequently engaged in a formal mediation conference before a neutral, private mediator on October 25, 2022, and have continued their settlement discussions into 2023. The Court has entered an Order providing for the filing of Chembio’s summary judgment motion, any opposition, and reply, by May 4, 2023. At this stage of the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.

Other

From time to time the Company may become involved in legal proceedings or may be subject to claims arising in the ordinary course of its business. Although the results of litigation and claims cannot be predicted with certainty, the Company currently believes that the final outcome of these ordinary course matters will not have a material adverse effect on its business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.

Nasdaq Communications

On April 5, 2022, the Company received notification from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, stating that the Company did not comply with the minimum $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”). In accordance with Nasdaq listing rules, the Company was afforded 180 calendar days (until October 3, 2022) to regain compliance with the Bid Price Requirement. On October 4, 2022, the Company received written notice from Nasdaq stating that, although the Company had not regained compliance with the Bid Price Requirement by October 3, 2022, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company is eligible for an additional 180 calendar day period, or until April 3, 2023, to regain compliance with the Bid Price Requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this additional 180-day period, all as described in more detail in the Current Reports on Form 8-K filed with the SEC on April 7, 2022 and October 4, 2022.

There can be no assurance that Chembio will be able to regain compliance with the Bid Price Requirement. The Company’s inability to regain compliance with the Bid Price Requirement would, and the existence of the pending deficiency letter could, materially impair its ability to raise capital. Moreover, if Chembio were unable to regain compliance with the Bid Price Requirement, its common stock would likely then trade only in the over-the-counter market and the market liquidity of its common stock could be adversely affected and its market price could decrease. If Chembio’s common stock were to trade on the over-the-counter market, selling Chembio’s common stock could be more difficult because smaller quantities of shares would likely be bought and sold, transactions could be delayed, and Chembio could face significant material adverse consequences, including: a limited availability of market quotations for its securities; reduced liquidity with respect to its securities; a determination that its shares are a “penny stock,” which will require brokers trading in its securities to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for its securities; a reduced amount of news and analyst coverage; and a decreased ability to issue additional securities or obtain additional financing in the future. These factors could result in lower prices and larger spreads in the bid and ask prices for its common stock and would substantially impair its ability to raise additional funds and could result in a loss of institutional investor interest and fewer development opportunities for Chembio.

SIGNIFICANT ACCOUNTING POLICIES, Valuation of Long-Lived Assets and Intangible Assets (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Valuation of Long-Lived Assets and Intangible Assets [Abstract]
Impairment of long-lived intangible assets	$ 0.0	$ 3.3
Impairment, Intangible Asset, Indefinite-Lived (Excluding Goodwill), Statement of Income or Comprehensive Income [Extensible Enumeration]	Impairment, restructuring, severance and related costs	Impairment, restructuring, severance and related costs

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS, Employment Contracts (Details)	Dec. 31, 2022 USD ($) KeyEmployee
Employment Contracts [Abstract]
Number of key employees with whom Company has employment contracts \| KeyEmployee	3
Future minimum salary commitments [Abstract]
2023	$ 1,178,000
2024	$ 383,000

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2022	Dec. 31, 2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Cash received from customers and grants	$ 53,886,080	$ 37,232,082
Cash received from insurance receivable	644,389	861,902
Cash paid to suppliers and employees	(63,624,525)	(65,273,967)
Cash paid for operating leases	(1,453,778)	(1,404,532)
Cash paid for finance leases	(17,015)	(20,077)
Interest and taxes, net	(2,129,104)	(2,281,124)
Net cash used in operating activities	(12,693,953)	(30,885,716)
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisition of and deposits on fixed assets	(1,451,233)	(1,824,285)
Patent application costs	0	(33,398)
Net cash used in investing activities	(1,451,233)	(1,857,683)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock, net	4,311,486	38,811,958
Proceeds from option exercises	0	85,555
Interest received on Employee Retention Credit	67,818	0
Principal payments for finance leases	(70,514)	(61,867)
Payments on note payable	(900,000)	0
Payments of tax withholding on stock award	(41,537)	(145,225)
Net cash provided by financing activities	3,367,253	38,690,421
Effect of exchange rate changes on cash	184,026	(240,431)
INCREASE IN CASH AND CASH EQUIVALENTS	(10,593,907)	5,706,591
Cash and cash equivalents - beginning of the period	28,772,892	23,066,301
Cash and cash equivalents - end of the period	18,178,985	28,772,892
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Net Loss	(23,290,657)	(33,903,529)
Adjustments:
Depreciation and amortization	2,552,969	2,930,976
Share based compensation	2,299,081	2,431,982
Benefit from deferred tax liability	0	(69,941)
Provision for (recovery of) doubtful accounts	103,854	(53,751)
Non-cash inventory changes	569,430	4,054,701
Impairment charges	3,033,565	5,880,741
Changes in assets and liabilities:
Accounts receivable	4,800,838	(8,009,969)
Inventories	4,635,608	(4,458,750)
Prepaid expenses and other current assets	(2,124,366)	(545,305)
Insurance receivable, current	(12,186,322)	0
Deposits and other assets	(76,862)	(234,874)
Insurance receivable, long-term	386,205	(386,205)
Accounts payable and accrued liabilities	6,602,704	3,085,205
Deferred revenue	0	(1,606,997)
Net cash used in operating activities	$ (12,693,953)	$ (30,885,716)

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2022	Dec. 31, 2021
REVENUES:
REVENUES	$ 49,521,923	$ 47,818,452
COSTS AND EXPENSES:
Cost of product sales	38,578,098	34,495,802
Research and development expenses	7,067,852	12,487,424
Selling, general and administrative expenses	24,277,834	24,840,611
Impairment, restructuring, severance and related costs	3,236,186	7,047,779
TOTAL COSTS AND EXPENSES	73,159,970	78,871,616
LOSS FROM OPERATIONS	(23,638,047)	(31,053,164)
OTHER INCOME (EXPENSE):
Interest (expense)/ income, net	(2,812,772)	(2,912,415)
Other income	3,194,567	0
LOSS BEFORE INCOME TAXES BENEFIT	(23,256,252)	(33,965,579)
Income tax (expense)/benefit	(34,405)	62,050
NET LOSS	$ (23,290,657)	$ (33,903,529)
Basic loss per share (in dollars per share)	$ (0.72)	$ (1.4)
Diluted loss per share (in dollars per share)	$ (0.72)	$ (1.4)
Weighted average number of shares outstanding, basic (in shares)	32,269,147	24,299,465
Weighted average number of shares outstanding, diluted (in shares)	32,269,147	24,299,465
Net Product Sales [Member]
REVENUES:
REVENUES	$ 47,091,673	$ 34,737,444
R&D Revenue [Member]
REVENUES:
REVENUES	112,986	1,159,381
Government Grant Income [Member]
REVENUES:
REVENUES	1,182,023	10,891,726
License and Royalty Revenue [Member]
REVENUES:
REVENUES	$ 1,135,241	$ 1,029,901

SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2022

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES:

(a) Basis of Presentation:

The accompanying consolidated financial statements include the accounts of Chembio and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. Certain reclassifications have been made to the consolidated balance sheet of the prior year to conform to the current year presentation.

Going Concern Considerations

The Company continued to experience market, clinical trial and regulatory complications in seeking to develop and commercialize a portfolio of COVID-19 test systems during the continuing, but evolving, uncertainty resulting from COVID‑19. For the year ended December 31, 2022, the Company also continued to incur significant operating losses and significant expenses in connection with pending legal matters (see Note 12 – Commitments, Contingencies, and Concentrations: Litigation).

The Company performed an assessment to determine whether there were conditions or events that, considered in the aggregate, raised substantial doubt about the Company’s ability to continue as a going concern within one year after the filing date of this report, when the accompanying financial statements are being issued. Initially, this assessment did not consider the potential mitigating effect of management’s plans that had not been fully implemented. Because, as described below, substantial doubt was determined to exist as the result of this initial assessment, management then assessed the mitigating effect of its plans to determine if it is probable that the plans (1) would be effectively implemented within one year after the filing date of this report, when the accompanying financial statements are being issued and (2) when implemented, would mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern.

The Company achieved revenue growth in recent years while profitability has not been at expected levels. It has taken steps including investments in automation to mitigate headwinds such as labor availability, volatile capacity planning and implementation of operational efficiency targets to proactively monitor production with the overarching goal of profitable growth. The Company undertook measures to increase its total revenues and improve its liquidity position by continuing to develop the Global Competitiveness Program. The main pillars of the Global Competitiveness Program include the following:

•	Focus on higher margin business in growth markets

•	Lower manufacturing costs

•	Reduce infrastructure costs

•	Strategic review of non-core businesses and assets

The Company’s execution of its plan continues to depend on factors and uncertainties that are beyond the Company’s control, or that may not be addressable on terms acceptable to the Company or at all. The Company considered in particular how the ongoing healthcare and economic impacts of COVID-19 on the global customer base for the Company’s non‑COVID-19 products continue to negatively affect the timing and rate of recovery of the Company’s revenues from those products.

The Company further considered how these factors and uncertainties could impact its ability over the next year to meet the obligations specified in the Credit Agreement with the Lender. Those obligations include covenants requiring: i) minimum cash balance of $3.0 million and ii) minimum total revenue amounts for the twelve months preceding each quarter end. The minimum total revenue requirements are $48.8 million for the twelve months ending March 31, 2023 and $50.1 million for the twelve months ending June 30, 2023. We do not believe that we will comply with the minimum total revenue covenant for the twelve months ended March 31, 2023. Upon an event of default under the Credit Agreement, the Lender could elect to declare all amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. Furthermore, all remaining principal and interest is due on or before September 3, 2023. There can be no assurance that the Company would have sufficient liquidity to fund payment of the amounts that would be due under the Credit Agreement or that, if such liquidity were not available, the Company would be successful in raising additional capital on acceptable terms, or at all, or in completing any other endeavor to continue to be financially viable and continue as a going concern. The Company’s inability to raise additional capital on acceptable terms in the near future, whether for purposes of funding payments required under the Credit Agreement or providing additional liquidity needed for its operations, could have a material adverse effect on its business, prospects, results of operations, liquidity and financial condition and would likely result in the Company being forced to seek protection under a bankruptcy proceeding.

Accordingly, management determined the Company could not be certain that the Company’s plans and initiatives would be effectively implemented within one year after the filing date of this report, when the accompanying financial statements are being issued. Without giving effect to increasing product revenue in the near future, the proposed merger with Biosynex or executing other mitigating plans, many of which are beyond the Company’s control, it is unlikely that the Company will be able to generate sufficient cash flows to meet its required financial obligations, including its debt service and other obligations due to third parties. The existence of these conditions raises substantial doubt about the Company’s ability to continue as a going concern for the twelve-month period following the date on which the accompanying consolidated financial statements are being issued.

The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date the accompanying consolidated financial statements are issued. As such, the accompanying consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.

(b) Use of Estimates:

The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make assumptions and estimates that affect the amounts reported in the consolidated financial statements and accompanying notes. Judgments and estimates of uncertainties are required in applying the Company’s accounting policies in certain areas. Generally, matters subject to estimation and judgment include accounts receivable realization, inventory obsolescence, asset impairments, recognition of revenue, useful lives of fixed assets, stock-based compensation, insurance recoveries, and deferred tax asset valuation allowances. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based upon amounts that differ from those estimates.

The carrying value for cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash equivalents is $18.2 million and $28.8 million as of December 31, 2022 and 2021, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company’s total debt of $19.1 million (carrying value of $18.6 million) and $20 million (carrying value of $18.8 million) as of December 31, 2022 and 2021, respectively, is a Level 2 fair value measurement under the hierarchy, and the carrying value approximates fair value.

Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:

Level 1:

Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2:

Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3:

Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

(d) Cash and Cash Equivalents:

Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of three months or less at date of purchase.

(e) Concentrations of Credit Risk:

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and trade receivables. The Company places its cash with well-known financial institutions and, at times, may maintain balances in excess of the FDIC insurance limit.

(f) Inventory:

Inventories are stated at the lower of cost or net realizable value with cost being determined using a standard cost method, which approximates average cost. Average cost consists primarily of material, labor and manufacturing overhead expenses (including fixed production-overhead costs). The Company analyzes its inventory levels quarterly and writes down, in the applicable period, inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected customer demand.

(g) Fixed Assets:

Fixed assets are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, which range from three to seven years. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Deposits paid for fixed assets are capitalized and not depreciated until the related asset is placed in service.

(h) Valuation of Long-Lived Assets and Intangible Assets:

Long-lived assets to be held and used are analyzed for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. The Company evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment. If there are indications of impairment, the Company uses future undiscounted cash flows of the related asset or asset grouping over the remaining life in measuring whether the assets are recoverable. In the event such cash flows are not expected to be sufficient to recover the recorded asset values, the assets are written down to their estimated fair value. A $0 and $3.3 million impairment of long-lived intangible assets was recorded for the years ended December 31, 2022 and 2021 (see Note 14 - Asset Impairment, Restructuring, Severance and related costs).

(i) Revenue Recognition:

The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under Accounting Standards Update (“ASU”) 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation.

Product Revenue

Revenue from product sales are recognized and commissions are accrued when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon tendering the product to the customer. The Company expenses incremental costs of obtaining a contract as and when incurred because the expected amortization period of the asset that it would have recognized is one year or less or the amount is immaterial. Freight and distribution activities on products are performed when the customer obtains control of the goods. The Company has made an accounting policy election to account for shipping and handling activities that occur either when or after goods are tendered to the customer as a fulfillment activity, and therefore recognizes freight and distribution expenses in cost of product sales. The Company excludes certain taxes from the transaction price (e.g., sales, value added and some excise taxes).

The Company’s contracts with customers often include promises to transfer products or services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require judgment. Typical products sold are diagnostic tests and typical services performed are R&D studies. Revenues from product sales are recognized at a point-in-time and revenues from R&D studies are recognized ratably over the period of the agreement, unless the related performance obligations indicate otherwise.

Judgment is required to determine the stand-alone selling price (“SSP”) for each distinct performance obligation. SSP is directly observable and the Company can use a range of amounts to estimate SSP, as it sells products and services separately, and can determine whether there is a discount to be allocated based on the relative SSP of the various products and services, for the various geographies.

From time to time the Company engages in bill-and-hold arrangements, whereby the Company manufactures and sells its product and at the customer’s request stores the product at the Company’s warehouse. Even though the product remains in the Company’s possession, a sale is recognized at the point in time when the customer obtains control of the product. Control is transferred to the customer in bill and hold transactions when: customer acceptance specifications have been met, legal title has transferred, the customer has a present obligation to pay for the product and the risk and rewards of ownership have transferred to the customer. Additionally, all the following bill and hold criteria would have to be met in order for control to be transferred to the customer:

(a)	The reason for the bill-and-hold arrangement must be substantive (for example, the customer has requested the arrangement).

(b)	The product must be identified separately as belonging to the customer.

(c)	The product currently must be ready for physical transfer to the customer.

(d)	The entity cannot have the ability to use the product or to direct it to another customer.

The Company’s payment terms vary by the type and location of the Company’s customer and products or services offered. Payment terms differ by jurisdiction and customer, but payment is generally required in a term ranging from 30 to 60 days from date of shipment or satisfaction of the performance obligation.

Reserves for Discounts and Allowances

Revenue from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers.

Product revenue reserves, which are classified as a reduction in product revenue, are generally related to discounts and returns. Estimates of variable consideration and the determination of whether to include estimated amounts in the transaction price are based on all information (historical, current, and forecasted) that is reasonably available to the Company, taking into consideration the type of customer, the type of transaction, market events and trends, and the specific facts and circumstances of each arrangement. The transaction price, which includes variable consideration reflecting the impact of discounts, allowances and returns may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the revenue recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on revenue and earnings in the period of adjustment.

License and Royalty Revenues

The Company receives royalty revenue on sales by its licensee of products covered under patents that the Company owns. The Company does not have future performance obligations under this license arrangement. The Company records revenue based on estimates of the sales that occurred during the relevant period as a component of license and royalty revenue. The relevant period estimates of sales are based on interim data provided by the licensee and analysis of historical royalties that have been paid to the Company, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenue are adjusted for in the period in which they become known, typically the following quarter. Historically, adjustments have not been material when compared to actual amounts paid by licensees.

R&D Revenue

All contracts with customers are evaluated under the five-step model described above. Such contracts are further described in Note 6 - Revenue. Grants are invoiced and revenue is recognized ratably as that is the depiction of the timing of the transfer of services. The R&D study, which encompasses various phases of product development processes: design feasibility & planning, product development and design optimization, design verification, design validation and process validation, and pivotal studies, is also recognized ratably.

For certain contracts that represent non-governmental grants where the funder does not meet the definition of a customer, the Company recognizes revenue when earned in accordance with Accounting Standards Codification (“ASC”) Topic 958.

Government Grant Income

Chembio receives government grants in support of R&D activities that are not associated with a customer-vendor relationship and therefore falls outside the scope of ASC 606. Because there is no authoritative guidance under U.S. GAAP on accounting for government grants received, Chembio applies Topic 958 - Not-for-profit entities guidance by analogy. In June 2018, the Financial Accounting Standards Board (the “FASB”) issued ASU 2018-08, Not-for-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made. This ASU clarifies the guidance presented in ASC Topic 958, “Not-for-Profit Entities,” for evaluating whether a transaction is reciprocal (i.e., an exchange transaction) or non reciprocal (i.e., a contribution) and for distinguishing between conditional and unconditional contributions. The ASU also clarified the guidance used by entities other than not-for-profits to identify and account for contributions made. Government grants are invoiced and revenue is recognized as milestones are achieved, conditions are removed and approval from grantor is obtained.

In July 2020, the Company was awarded a grant of $0.6 million from BARDA to develop a SARS-CoV-2 Ag System. The Company earned $0 and $0.2 million for the years ended December 31, 2022 and 2021, respectively, and was recorded as government grant income.

In December 2020, the Company was awarded a grant of $12.7 million from BARDA to support the development and pursuit of FDA EUA for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system. The Company earned $0 and $10.9 million for the years ended December 31, 2022 and 2021, respectively, and was recorded as government grant income. Cumulative through December 31, 2022, the Company recognized $12.5 million under this agreement, and the remainder $0.2 million is subject to obtaining the EUA for the DPP SARs-COV-2 Antigen test.

In September 2022, the Company was awarded a grant of $3.2 million from the Centers for Disease Control and Prevention (CDC) to develop a rapid POC Syphilis Diagnostic Test using Chembio DPP Technology. As of December 31, 2022, the company earned $0.6 million that was recorded as government grant income.

Contract Liabilities

Deferred revenue relates to payments received in advance of performance under the contract. Deferred revenue is recognized as revenue as (or when) the Company performs under the contract. At December 31, 2022 and 2021, the Company reported $0 in deferred revenue.

(j) Loss Per Share:

Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period excluding unvested restricted stock. Diluted net loss per share is computed using the treasury stock method if the additional shares are dilutive. For all periods presented, basic and diluted net loss per share are the same as any additional shares would be anti-dilutive.

There were 1,588,387 and 705,325 restricted shares awards outstanding as of December 31, 2022 and 2021, respectively, that were not included in the calculation of diluted income per share for the year ended December 31, 2022 and 2021, because their effect would have been anti-dilutive. There were 3,657,163 and 1,600,372 options outstanding as of December 31, 2022 and 2021 respectively, that were not included in the calculation of diluted income per share for the twelve months ended December 31, 2022 and 2021, respectively, because their effect would have been anti-dilutive.

(k) Research and Development:

Research and Development (R&D) include product development, program management, clinical trials and regulatory costs and are expensed when incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

(l) Stock-Based Compensation:

The Company grants share options to employees and non-employee members of the Company’s board of directors as compensation for services performed. Employee and non-employee members of the board of directors’ awards of share-based compensation are accounted for in accordance with ASC 718, Compensation - Stock Compensation, or ASC 718. ASC 718 requires all share-based payments to employees and non-employee directors, including grants of share options, to be recognized in the consolidated statement of operations and comprehensive loss based on their grant date fair values.

The grant date fair value of share options is estimated using the Black-Scholes option valuation model. The fair value of restricted stock and performance/restricted stock unit awards are determined on the date of grant or the date of issuance, as applicable.

The grant date fair value is calculated based on assumptions with respect to (i) the fair value of the Company’s common stock on the grant date; (ii) expected volatility of the Company’s common stock price, (iii) the periods of time over which the optionees are expected to hold their options prior to exercise (expected term), (iv) expected dividend yield on the Company’s common stock, and (v) risk-free interest rates.

The expected volatility is calculated based on historical data of the Company’s common stock. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. Risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the option’s expected term. The expected term of share options granted to the optionees is determined using the average of the vesting period and contractual life of the option.

Stock based compensation is generally recognized on a straight-line basis over the service period of the grant and is reduced for actual forfeitures in the period in which the forfeiture occurs.

(m) Income Taxes:

The Company accounts for income taxes under an asset and liability approach that recognizes deferred tax assets and liabilities based on the difference between the financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse.

The Company follows a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The guidance relates to, among other things, classification, accounting for interest and penalties associated with tax positions, and disclosure requirements. Any interest and penalties accrued related to uncertain tax positions are recorded in tax expense.

The Company assesses the realizability of its net deferred tax assets on an annual basis. If, after considering all relevant positive and negative evidence, it is more likely than not that some portion or all of the net deferred tax assets will not be realized, the Company will reduce the net deferred tax assets by a valuation allowance. The realization of net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of net operating loss carryforwards.

(n) Goodwill:

Goodwill represents the excess of the purchase price the Company paid over the fair value of the net tangible and identifiable intangible assets acquired in the Company’s acquisition. Goodwill is not amortized but rather is tested annually as of the first day of the fiscal fourth quarter, or sooner if the Company believes that indicators of impairment exist. The Company makes a qualitative evaluation about the likelihood of goodwill impairment, which is based on a number of applicable factors. If the Company concludes that it is more likely than not that the carrying value of the applicable reporting unit is greater than its fair value, then it would recognize an impairment charge for the amount by which the carrying value exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit.

The quantitative goodwill impairment test is performed using a one-step process. The process is to compare the fair value of a reporting unit with its carrying amount. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is not impaired. If the carrying amount of a reporting unit exceeds its fair value, goodwill of the reporting unit is impaired, and an impairment loss is recognized in an amount equal to that excess.

The Company operates as a single operating segment and has one reporting unit. The Company recognized an impairment loss of its goodwill totaling $3.0 and $2.6 million for the year ended December 31, 2022 and 2021 respectively.

(o) Allowance for Doubtful Accounts:

The Company records allowances for doubtful accounts for the estimated probable losses on uncollectible accounts receivable. The allowance is based upon the credit worthiness of the Company’s customers, the Company’s historical experience, the age of the receivable and current market and economic conditions. Receivables are written off against these allowances in the period they are determined to be uncollectible.

(p) Foreign Currency Translation:

The functional currency of a foreign subsidiary is the local currency. Assets and liabilities of foreign subsidiaries that use a currency other than U.S. dollars as their functional currency are translated to U.S. dollars at end of period currency exchange rates. The consolidated statements of operations of foreign subsidiaries are translated to U.S. dollars at average period currency exchange rates. The effect of translation for foreign subsidiaries is reported in other comprehensive income.

(q) Leases:

The Company accounts for leases in accordance with ASC 842. The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the Company has the right to control the use of the identified asset. The Company accounts for the lease and non-lease components as a single lease component.

From time to time the Company enters into direct financing lease arrangements that include a lessee obligation to purchase the leased asset at the end of the lease term, a bargain purchase option, or provides for minimum lease payments with a present value of 90% or more of the fair value of the leased asset at the date of lease inception.

Operating leases where the Company is the lessee are included in right-of-use (“ROU”) assets and lease obligations are included on the Company’s consolidated balance sheets. The lease obligations are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date and subsequent reporting periods.

Finance leases where the Company is the lessee are included in ROU assets and lease obligations on the Company’s consolidated balance sheets. The lease obligations are initially measured in the same manner as for operating leases and are subsequently measured at amortized cost using the effective interest method.

Key estimates and judgments include how the Company determined (1) the discount rate used to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As most of the Company’s leases where it is the lessee do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company uses the implicit rate when readily determinable.

The lease term for all of the Company’s leases includes the noncancelable period of the lease plus any additional periods covered by either a lessee option to extend (or not to terminate) the lease that is reasonably certain to be exercised, or an option to extend (or not to terminate) the lease controlled by the lessor.

The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, minus any accrued lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset, or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense on the lease liability.

The Company has elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less at lease commencement. Lease payments associated with short-term leases are recognized as an expense on a straight-line basis over the lease term.

Impairment charges for the Malaysian facility right-of-use asset recorded during the years ended December 31, 2022 and 2021 was $0 and $0.1 million, respectively (see Note 14 - Asset Impairment, Restructuring, Severance and related costs).

(r) Employee Retention Credit

Accounting Standards Codification 105, “Generally Accepted Accounting Principles,” describes the decision-making framework when no clear guidance exists in US GAAP for a particular transaction. Specifically, ASC 105-10-05-2 instructs companies to look for guidance for a similar transaction within US GAAP and apply that guidance by analogy. As such, forms of government assistance, such as the Employee Retention Credit, provided to business entities would not be within the scope of International Accounting Standards (IAS) 20 Accounting for Government Grants and Disclosure of Government Assistance, but it may be applied by analogy under ASC 105-10-05-2. We accounted for the Employee Retention Credit (“ERC”) as a government grant in accordance with IAS 20 by analogy under ASC 105-10-05-2 and a current receivable and other income was recorded for the year ended December 31, 2022.

(s) Insurance Receivable

Upon the recognition of a loss related to a pending, threatened or actual litigation for which the Company has insurance coverage, a related insurance receivable is recorded upon evaluation that an insurance contract is enforceable and the insurer has not disputed the claim. If the insurance is enforceable and not subject to dispute, the Company recognizes a receivable from the insurer when it is probable of recovery up to the loss recognized.

(t) Recent Accounting Pronouncements Affecting the Company:

Recently Adopted

ASU 2021-10 - Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance

In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which creates Accounting Standards Codification (“ASC”) 832 and aims to provide increased transparency by requiring business entities to disclose information about certain types of government assistance they receive in the notes to the financial statements. The disclosure requirements in ASC 832 only apply to transactions with a government that are accounted for by analogizing to either a grant model (for example, in International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance), or a contribution model (for example, in ASC 958-605, Not-for-Profit Entities – Revenue Recognition). The FASB broadly defined “government assistance” in ASC 832 to ensure that assistance received from most types of governmental entities or other related organizations would be disclosed. Entities are required to provide the new disclosures prospectively for all transactions with a government entity that are accounted for under either a grant or a contribution accounting model and are reflected in the financial statements at the date of initially applying the new amendments, and to new transactions entered into after that date. Retrospective application of the guidance is permitted. The Company adopted the standard effective January 1, 2022 and has determined that the adoption did not have an impact on the Company’s consolidated financial statements.

Not Yet Adopted

ASU 2020-06 - Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity

On August 5, 2020, the FASB issued ASU 2020-06, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in GAAP. ASU 2020-06 simplifies the guidance in GAAP on the issuer’s accounting for convertible debt instruments, requires entities to provide expanded disclosures about “the terms and features of convertible instruments” and how the instruments have been reported in the entity’s financial statements. It also removes from ASC 815-40-25-10 certain conditions for equity classification and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and contracts on an entity’s own equity. An entity can use either a full or modified retrospective approach to adopt the ASU’s guidance. The ASU’s amendments are effective for smaller public business entities fiscal years beginning after December 15, 2023. The Company continues to assess the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2022	Dec. 31, 2021
CURRENT ASSETS:
Cash and cash equivalents	$ 18,178,985	$ 28,772,892
Accounts receivable, net of allowance for doubtful accounts of $346,896 and $243,042 at December 31, 2022 and 2021, respectively	6,536,415	11,441,107
Inventories, net	7,715,413	12,920,451
Prepaid expenses and other current assets	3,834,560	1,710,194
Insurance receivable, current	12,186,322	0
TOTAL CURRENT ASSETS	48,451,695	54,844,644
FIXED ASSETS:
Property, plant and equipment, net	8,154,651	8,556,773
Finance lease right-of-use assets, net	136,976	191,870
OTHER ASSETS:
Operating right-of-use assets, net	5,433,211	5,891,906
Goodwill	0	3,022,787
Deposits and other assets	434,872	358,010
Insurance receivable, long-term	0	386,205
TOTAL ASSETS	62,611,405	73,252,195
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	19,730,697	13,127,993
Current portion of long term debt	18,577,693	1,200,000
Operating lease liabilities	914,857	886,294
Finance lease liabilities	76,869	68,176
TOTAL CURRENT LIABILITIES	39,300,116	15,282,463
OTHER LIABILITIES:
Long-term operating lease liabilities	5,426,030	5,976,151
Long-term finance lease liabilities	76,705	139,678
Long-term debt, less current portion, net	10,197	17,589,003
TOTAL LIABILITIES	44,813,048	38,987,295
COMMITMENTS AND CONTINGENCIES (Note 12)
STOCKHOLDERS' EQUITY:
Preferred stock - 10,000,000 shares authorized; none outstanding	0	0
Common stock - $0.01 par value; 100,000,000 shares authorized, 36,765,785 and 30,104,986 shares issued and outstanding at December 31, 2022 and 2021, respectively	367,658	301,050
Additional paid-in capital	172,275,057	165,772,636
Accumulated deficit	(154,300,517)	(131,009,860)
Treasury Stock - 48,057 and 48,057shares at cost, at December 31, 2022 and 2021, respectively	(206,554)	(206,554)
Accumulated other comprehensive loss	(337,287)	(592,372)
TOTAL STOCKHOLDERS' EQUITY	17,798,357	34,264,900
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 62,611,405	$ 73,252,195

SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2022

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

Basis of Presentation

(a) Basis of Presentation:

Use of Estimates

(b) Use of Estimates:

Fair Value of Financial Instruments

Level 1:

Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2:

Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3:

Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

Cash and Cash Equivalents

(d) Cash and Cash Equivalents:

Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of three months or less at date of purchase.

Concentrations of Credit Risk

(e) Concentrations of Credit Risk:

Inventory

(f) Inventory:

Fixed Assets

(g) Fixed Assets:

Valuation of Long-Lived Assets and Intangible Assets

(h) Valuation of Long-Lived Assets and Intangible Assets:

Revenue Recognition

(i) Revenue Recognition:

Product Revenue

(a)	The reason for the bill-and-hold arrangement must be substantive (for example, the customer has requested the arrangement).

(b)	The product must be identified separately as belonging to the customer.

(c)	The product currently must be ready for physical transfer to the customer.

(d)	The entity cannot have the ability to use the product or to direct it to another customer.

Reserves for Discounts and Allowances

Revenue from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers.

License and Royalty Revenues

R&D Revenue

Government Grant Income

Contract Liabilities

Loss Per Share

(j) Loss Per Share:

Research and Development

(k) Research and Development:

Stock-Based Compensation

(l) Stock-Based Compensation:

Stock based compensation is generally recognized on a straight-line basis over the service period of the grant and is reduced for actual forfeitures in the period in which the forfeiture occurs.

Income Taxes

(m) Income Taxes:

Goodwill

(n) Goodwill:

Allowance for Doubtful Accounts

(o) Allowance for Doubtful Accounts:

Foreign Currency Translation

(p) Foreign Currency Translation:

Leases

(q) Leases:

Employee Retention Credit

(r) Employee Retention Credit

Insurance Receivable

(s) Insurance Receivable

Recent Accounting Pronouncements Affecting the Company

(t) Recent Accounting Pronouncements Affecting the Company:

Recently Adopted

ASU 2021-10 - Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance

Not Yet Adopted

INVENTORIES (Tables)

12 Months Ended

Dec. 31, 2022

INVENTORIES [Abstract]

Inventory

Net inventories consist of the following at December 31:

	December 31
	2022		2021
Raw Materials	$	4,539,346	$	7,306,095
Work in Process		1,106,962		3,556,878
Finished Goods		2,069,105		2,057,478
	$	7,715,413	$	12,920,451

EQUITY INCENTIVE PLANS

12 Months Ended

Dec. 31, 2022

EQUITY INCENTIVE PLANS [Abstract]

EQUITY INCENTIVE PLANS

NOTE 10 — EQUITY INCENTIVE PLANS:

Effective June 19, 2014, Chembio’s stockholders voted to approve the 2014 Stock Incentive Plan (the “2014 Plan”), with 800,000 shares of common stock available to be issued. Under the terms of the 2014 Plan, the Board or its Compensation Committee has the discretion to select the persons to whom awards are to be granted. Awards can be in the form of Equity Award Units. The awards vest at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through December 31, 2022, there were 732,064 Equity Award Units expired, forfeited or exercised. At December 31, 2022, 46,875 Equity Award Units were outstanding and 21,061 shares were not issued. All shares that expired, forfeited or were not issued rolled over into the 2019 Plan. No Equity Award Units remain available to be issued under the 2014 Plan.

Effective June 18, 2019, Chembio’s stockholders voted to approve the 2019 Omnibus Incentive Plan (the “2019 Plan”), with 2,400,000 shares of common stock available to be issued. At the Annual Stockholder Meeting on June 25, 2021, Chembio’s stockholders voted to approve an increase to the shares of common stock issuable under the SIP by 2,400,000 to 4,800,000. In addition, shares of common stock underlying any outstanding award granted under the 2019 Plan that, following the effective date of the 2019 Plan, expire, or are terminated, surrendered or forfeited for any reason without issuance of such shares, shall be available for the grant of new awards under the 2019 Plan. Under the terms of the 2019 Plan, the Board or its Compensation Committee has the discretion to select the persons to whom awards are to be granted. Awards can be in the form of options, stock appreciation rights, restricted stock, restricted stock units, performance stock units or other stock-based awards under the 2019 Plan (collectively, “2019 Equity Units”). The 2019 Equity Units become vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through December 31, 2022, 1,307,361 2019 Equity Units have been cancelled or forfeited. At December 31, 2022, 4,660,098 2019 Equity Units were outstanding, and 226,702 2019 Equity Units were available to be awarded.

The Company’s results for the years ended December 31, 2022 and 2021 include stock-based compensation expense totaling $2,299,081 and $2,034,247, respectively. Such amounts have been included in the Consolidated Statements of Operations within cost of product sales ($209,792 and $174,537, respectively), research and development ($446,769 and $494,235, respectively) and selling, general and administrative expenses ($1,642,520 and $1,365,475, respectively).

The weighted-average assumptions made in calculating the fair values of options are as follows for the respective years ended December 31:

	2022			2021
Expected term (in years)		6.00			5.10
Expected volatility		91.62	%		78.95	%
Expected dividend yield		0			0
Risk-free interest rate		1.97	%		0.85	%

The following table provides stock option activity for the years ended December 31, 2022:

	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at December 31, 2021	1,600,372	$	4.18	6.59 years	$	-

Granted	2,481,968	$	1.24			-
Exercised	—	$	—			-
Forfeited	154,076	$	2.70			-
Expired/cancelled	271,101		5.01
Outstanding at December 31, 2022	3,657,163	$	2.20	8.05 years	$	-

Exercisable at December 31, 2022	581,574	$	3.98	5.42 years	$	-

The following table summarizes information about stock options outstanding at December 31, 2022:

	Stock Options Outstanding								Stock Options Exercisable
Range of Exercise Prices	Shares Outstanding		Average Remaining Contract Life (Year)		Weighted Average Exercise Price		Aggregate Intrinsic Value		Shares Exercisable		Weighted Average Exercise Price		Aggregate Intrinsic Value
1 to 2.79999		2,824,519		8.26	$	1.40	$	-		266,431	$	2.36	$	-
2.8 to 4.59999		26,335		8.43		3.06		-		8,776		3.06		-
4.6 to 6.39999		759,434		7.69		4.80		-		259,492		4.93		-
6.4 to 8.19999		46,875		0.36		8.15		-		46,875		8.15		-
Total		3,657,163		8.04	$	2.20	$	-		581,574	$	3.98	$	-

As of December 31, 2022, there was $2,113,275 of net unrecognized compensation cost related to stock options that are not vested, which is expected to be recognized over a weighted average period of approximately 2.61 years. The total fair value of shares vested during the year ended December 31, 2022, was $962,801.

The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2022:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Unvested at December 31, 2021		705,325	$	3.34

Granted		1,308,547		0.75
Vested		203,839		3.75
Forfeited/expired/cancelled		221,646		1.35
Unvested at December 31, 2022		1,588,387		1.34

As of December 31, 2022, there was $1,259,000 of net unrecognized compensation cost related to restricted stock and restricted stock units that are not vested, which is expected to be recognized over a weighted average period of approximately 1.79 years. Stock based compensation cost related to restricted stock and restricted stock units recognized during the years ended December 31, 2022 and 2021 was $967,262 and $1,160,953, respectively.

One-Time Incentive Bonuses.

In August 2021 the board of directors approved the adoption of a One-Time Incentive Plan, or the OTIP, under which up to $1.5 million, was made available for cash awards to a number of employees, including executives.

The company made OTIP payments of $0.6 million and $0.1 million for years ending December 31, 2022 and 2021, respectively.

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]
Accounts Payable - suppliers	$ 3,342,926	$ 7,745,592
Accrued Commissions & Royalties	2,425,302	1,359,691
Accrued Payroll	330,784	494,258
Accrued Vacation	400,409	421,416
Accrued Bonuses	1,467,756	1,378,706
Accrued Professional Fees	114,000	122,935
Accrued Legal	11,182,997	400,000
Accrued Expenses - Other	466,523	1,205,395
TOTAL	$ 19,730,697	$ 13,127,993

EQUITY INCENTIVE PLANS, Restricted Stock and Restricted Stock Units (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Weighted Average Grant Date Fair Value [Abstract]
Allocated share-based compensation expense	$ 2,299,081	$ 2,034,247
Restricted Stock and Restricted Stock Units [Member]
Number of Shares & Units [Abstract]
Outstanding, beginning of period (in shares)	705,325
Granted (in shares)	1,308,547
Vested (in shares)	203,839
Forfeited/expired/cancelled (in shares)	221,646
Outstanding, end of period (in shares)	1,588,387	705,325
Weighted Average Grant Date Fair Value [Abstract]
Outstanding, beginning of period (in dollars per share)	$ 3.34
Granted (in dollars per share)	0.75
Vested (in dollars per share)	3.75
Forfeited/expired/cancelled (in dollars per share)	1.35
Outstanding, end of period (in dollars per share)	$ 1.34	$ 3.34
Net unrecognized compensation cost	$ 1,259,000
Weighted average period for recognition of net unrecognized compensation cost	1 year 9 months 14 days
Allocated share-based compensation expense	$ 967,262	$ 1,160,953

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details)	12 Months Ended
	Dec. 31, 2022 USD ($) Segment Group	Dec. 31, 2021 USD ($)
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]
Number of groups of similar products \| Group	1
Number of reportable segments \| Segment	1
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	$ 49,521,923	$ 47,818,452
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	8,154,651	8,556,773
Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	47,091,673	34,737,444
Africa [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	7,000,085	5,562,788
Africa [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	7,000,085	5,562,787
Asia [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	665,159	664,579
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	81,536	86,041
Asia [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	626,210	664,579
Europe & Middle East [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	4,518,475	5,179,267
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	74,815	113,883
Europe & Middle East [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	3,351,003	4,067,682
Latin America [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	19,265,840	18,418,983
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	81,315	36,224
Latin America [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	19,253,504	18,418,983
United States [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	18,072,364	17,992,835
Geographic Areas, Long-Lived Assets [Abstract]
Property, plant and equipment, net	7,916,985	8,320,625
United States [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net product revenue	$ 16,860,871	$ 6,023,413

IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS

12 Months Ended

Dec. 31, 2022

IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS [Abstract]

IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS

NOTE 14 — IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS:

Impairment, restructuring, severance and related costs include an impairment loss of $3.0 million during the first quarter of 2022 as a result of an impairment of goodwill due to the substantial decrease in our share price at March 31, 2022. The low price per share value at March 31, 2022 caused our book value to exceed our fair value. In addition, for the year ended December 31, 2022, $0.2 million was recorded which was related to severance charges. For the year ended 2021, the Company recorded an impairment loss of $7.0 million, of which $5.9 million was related to the write-off of intangible assets, net leasehold improvements, and net right-of-use assets for leases associated with our Malaysian operations, and $1.1 million was related to restructuring matters.

In order to address challenging economic conditions and implement its business strategy, in the first quarter of 2022 the Company continued to execute a program to reduce operating expenses and better align its costs with revenues, including by eliminating positions that were no longer aligned with its strategy, and recognized severance charges of $0.1 million.

The table below represents the total costs by category:

	For the year ended December 31, 2022		For the year ended December 31, 2021
Severance	$	202,621	$	83,087
Restructuring costs		-		1,083,951
Impairment		3,033,565		5,880,741
	$	3,236,186	$	7,047,779

SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition (Details) - USD ($)	1 Months Ended			12 Months Ended
	Sep. 30, 2022	Dec. 31, 2020	Jul. 31, 2020	Dec. 31, 2022	Dec. 31, 2021
Product Revenue [Abstract]
Term over which revenue will be recognized				1 year
Government Grant Income [Abstract]
Product sales				$ 49,521,923	$ 47,818,452
Deferred revenue				0	0
POC Syphilis Diagnostic Test [Member]
Government Grant Income [Abstract]
Maximum amount of development agreement	$ 3,200,000
SARS-CoV-2 Ag System [Member]
Government Grant Income [Abstract]
Maximum amount of development agreement			$ 600,000
Multiplex DPP Respiratory Antigen Panel Point-of-care Test system [Member]
Government Grant Income [Abstract]
Maximum amount of development agreement		$ 12,700,000
Government Grant Income [Member]
Government Grant Income [Abstract]
Product sales				1,182,023	10,891,726
Government Grant Income [Member] \| POC Syphilis Diagnostic Test [Member]
Government Grant Income [Abstract]
Product sales				600,000
Government Grant Income [Member] \| SARS-CoV-2 Ag System [Member]
Government Grant Income [Abstract]
Product sales				0	200,000
Remainder amount to be recognized subject to obtaining EUA				200,000
Government Grant Income [Member] \| Multiplex DPP Respiratory Antigen Panel Point-of-care Test system [Member]
Government Grant Income [Abstract]
Product sales				0	$ 10,900,000
Revenue recognized under agreement				$ 12,500,000
Minimum [Member]
Product Revenue [Abstract]
Revenue, payment terms				30 days
Maximum [Member]
Product Revenue [Abstract]
Revenue, payment terms				60 days

EQUITY INCENTIVE PLANS, Stock Options (Details)	12 Months Ended
EQUITY INCENTIVE PLANS, Stock Options (Details)	Dec. 31, 2022 USD ($) $ / shares shares
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	3,657,163
Average remaining contract life	8 years 14 days
Weighted average exercise price (in dollars per share)	$ 2.2
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	581,574
Weighted average exercise price (in dollars per share)	$ 3.98
Aggregate intrinsic value \| $	$ 0
1 to 2.79999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 1
Range of exercise prices, maximum (in dollars per share)	$ 2.79999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	2,824,519
Average remaining contract life	8 years 3 months 3 days
Weighted average exercise price (in dollars per share)	$ 1.4
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	266,431
Weighted average exercise price (in dollars per share)	$ 2.36
Aggregate intrinsic value \| $	$ 0
2.8 to 4.59999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 2.8
Range of exercise prices, maximum (in dollars per share)	$ 4.59999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	26,335
Average remaining contract life	8 years 5 months 4 days
Weighted average exercise price (in dollars per share)	$ 3.06
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	8,776
Weighted average exercise price (in dollars per share)	$ 3.06
Aggregate intrinsic value \| $	$ 0
4.6 to 6.39999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 4.6
Range of exercise prices, maximum (in dollars per share)	$ 6.39999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	759,434
Average remaining contract life	7 years 8 months 8 days
Weighted average exercise price (in dollars per share)	$ 4.8
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	259,492
Weighted average exercise price (in dollars per share)	$ 4.93
Aggregate intrinsic value \| $	$ 0
6.4 to 8.19999 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 6.4
Range of exercise prices, maximum (in dollars per share)	$ 8.19999
Stock Options Outstanding [Abstract]
Shares outstanding (in shares) \| shares	46,875
Average remaining contract life	4 months 9 days
Weighted average exercise price (in dollars per share)	$ 8.15
Aggregate intrinsic value \| $	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares) \| shares	46,875
Weighted average exercise price (in dollars per share)	$ 8.15
Aggregate intrinsic value \| $	$ 0

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2022

STOCKHOLDERS' EQUITY [Abstract]

STOCKHOLDERS' EQUITY

NOTE 9 — STOCKHOLDERS’ EQUITY:

(a)

Common Stock

On July 19, 2021, Chembio entered into an At the Market Offering Agreement (the “ATM Agreement”) with Craig‑Hallum Capital Group LLC (“Craig‑Hallum”), pursuant to which Chembio may sell from time to time, at its option, up to an aggregate of $60,000,000 of shares of common stock through Craig‑Hallum, as sales agent. During the year ended December 31, 2022, Chembio issued and sold pursuant to the ATM Agreement a total of 6,466,191 shares of common stock at a volume-weighted average price of $0.71 per share for gross proceeds of $4.6 million and net proceeds, after giving effect to placement fees and other transaction costs, of $4.3 million. Additional shares of common stock may be issued and sold pursuant to the ATM Agreement for gross proceeds of up to $6.3 million.

(b)

Preferred Stock

Chembio has 10,000,000 shares of preferred stock authorized and none outstanding. These shares can become issuable upon an approved resolution by the board of directors of Chembio (the “Board”) and the filing of a Certificate of Designation with the state of Nevada.

(c)

Treasury Stock

Chembio has 48,057 shares of treasury stock acquired upon the vesting of restricted stock awards related to the tax withholding requirements paid on behalf of the employees.

(d)

Options, Restricted Stock, and Restricted Stock Units

The Board or its Compensation Committee may make grants of options, restricted stock, and restricted stock units pursuant to equity incentive plans that have been approved by Chembio’s stockholders.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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+ Details

INCOME TAXES

12 Months Ended

Dec. 31, 2022

INCOME TAXES [Abstract]

INCOME TAXES

NOTE 7 — INCOME TAXES:

The components of loss before income taxes consisted of the following:

	Year Ending December 31,
	2022			2021
United States operations	$	(18,425,426	)	$	(26,858,325	)
International operations		(4,830,826	)		(7,107,254	)
Loss before taxes	$	(23,256,252	)	$	(33,965,579	)

The (benefit) provision for income taxes for the years ended December 31, 2022 and 2021 was comprised of the following:

	Year Ending December 31,
	2022		2021
Current
Federal	$	-	$	-
State		33,948		7,891
Foreign		457		-
Total current (benefit) provision		34,405		7,891

Deferred
Federal		-		-
State		-		-
Foreign		-		(69,941	)
Total deferred (benefit) provision		-		(69,941	)

Total (benefit) provision	$	34,405	$	(62,050	)

A reconciliation of the Federal statutory rate to the effective rate applicable to loss before income taxes is as follows:

	Year Ending December 31,
	2022			2021
Federal income tax at statutory rates		21.00	%		21.00	%
State income taxes, net of federal benefit		0.01	%		0.18	%
Nondeductible expenses		(3.69	)%		(2.04	)%
Foreign rate differential		0.40	%		0.32	%
Change in valuation allowance		(16.85	)%		(19.60	)%
Other		(1.02	)%		0.32	%
Income tax (expense) benefit		(0.15	)%		0.18	%

The Company had an ownership change as described in Internal Revenue Code Sec. 382 during 2004 (“2004 change”). As a result, the Company’s net operating losses prior to the 2004 change of $5,832,516 were subject to an annual limitation of $150,608 and for the first five (5) years are entitled to a BIG (Built-In-Gains) of $488,207 per year. These net operating losses expire in 2023 through 2024.

The Company had a second ownership change during 2006 (“2006 change”). The net operating losses incurred between the 2004 change and the 2006 change of $8,586,861 were subject to an annual limitation of $1,111,831 and for the first five (5) years are entitled to a BIG of $1,756,842 per year. These net operating losses expire in 2023 through 2026.

After applying the above limitations, at December 31, 2022, the Company has post-change net operating loss carry-forwards of approximately $25,671,216 which expire between 2023 and 2037 and $66,924,161 which do not expire. In addition the Company has research and development tax credit carryforwards of approximately $1,632,846 for the year ended December 31, 2022, which expire between 2023 and 2036.

The Company has state net operating loss carryforwards of approximately $4,746,769 which generally expire between 2035 and 2042. The Company has foreign net operating loss carryforwards of approximately $3,207,825 which generally expire between 2025 and 2029 and foreign net operating loss carryforwards of $5,803,963 which do not expire.

Deferred tax assets and liabilities as of December 31 are as follows:

	Year Ending December 31,
	2022			2021
Inventory reserves	$	343,262		$	333,551
Accrued expenses		822,145			374,673
Net operating loss carry-forwards		22,123,522			20,401,828
Research and development credit		1,632,846			1,651,529
Research and development expenses		628,711			-
Stock-based compensation		437,992			259,106
Interest Expense		1,825,347			1,221,171
Lease obligations		1,381,089			1,504,433
Intangibles		136,478			137,142
Total deferred tax assets		29,331,392			25,883,433

Right-of-use assets		(1,155,407	)		(1,294,519	)
Depreciation		(252,097	)		(560,754	)
Total deferred tax liabilities		(1,407,504	)		(1,855,273	)

Net deferred tax assets before valuation allowance		27,923,888			24,028,160
Less valuation allowances		(27,923,888	)		(24,028,160	)
Net noncurrent deferred tax liabilities	$	-		$	-

The Company does not provide for U.S. income taxes on unremitted earnings of foreign subsidiaries as its present intention is to reinvest the unremitted earnings in the Company’s foreign operations. At December 31, 2022 there were no unremitted earnings of foreign subsidiaries.

Interest and penalties, if any, related to income tax liabilities are included in income tax expense. As of December 31, 2022, the Company does not have any uncertain tax positions.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

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+ Details

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2022

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities consist of the following at December 31:

	December 31
	2022		2021
Accounts Payable - suppliers	$	3,342,926	$	7,745,592
Accrued Commissions & Royalties		2,425,302		1,359,691
Accrued Payroll		330,784		494,258
Accrued Vacation		400,409		421,416
Accrued Bonuses		1,467,756		1,378,706
Accrued Professional Fees		114,000		122,935
Accrued Legal		11,182,997		400,000
Accrued Expenses - Other		466,523		1,205,395
	$	19,730,697	$	13,127,993

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables)

12 Months Ended

Dec. 31, 2022

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

Product Sales by Geographic Area

The Company produces only one group of similar products known collectively as “rapid medical tests” and operates under one segment, as a single reporting unit. Product revenue by geographic area are as follows:

	Year Ending December 31,
	2022		2021
Africa	$	7,000,085	$	5,562,787
Asia		626,210		664,579
Europe & Middle East		3,351,003		4,067,682
Latin America		19,253,504		18,418,983
United States		16,860,871		6,023,413
	$	47,091,673	$	34,737,444

Long-lived Assets by Geographic Area

Property, plant and equipment, net by geographic area are as follows:

	2022		2021
Asia	$	81,536	$	86,041
Europe & Middle East		74,815		113,883
Latin America		81,315		36,224
United States		7,916,985		8,320,625
	$	8,154,651	$	8,556,773

SIGNIFICANT ACCOUNTING POLICIES, Going Concern Considerations (Details) - USD ($) $ in Millions	12 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022
Credit Agreement [Abstract]
Covenant amount, cash balance			$ 3.0
Forecast [Member]
Credit Agreement [Abstract]
Covenant amount, revenue	$ 50.1	$ 48.8

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

12 Months Ended

Dec. 31, 2022

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

NOTE 5 — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES:

Accounts payable and accrued liabilities consist of the following at December 31:

	December 31
	2022		2021
Accounts Payable - suppliers	$	3,342,926	$	7,745,592
Accrued Commissions & Royalties		2,425,302		1,359,691
Accrued Payroll		330,784		494,258
Accrued Vacation		400,409		421,416
Accrued Bonuses		1,467,756		1,378,706
Accrued Professional Fees		114,000		122,935
Accrued Legal		11,182,997		400,000
Accrued Expenses - Other		466,523		1,205,395
	$	19,730,697	$	13,127,993

As of December 31, 2022, the amounts in other accrued expenses include expenses in connection with pending legal matters (see Note 12 – Commitments, Contingencies, and Concentrations: Litigation).

SIGNIFICANT ACCOUNTING POLICIES, Loss Per Share (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Restricted Stock [Member]
Loss Per Share [Abstract]
Antidilutive securities excluded from calculation of diluted earnings per share (in shares)	1,588,387	705,325
Options [Member]
Loss Per Share [Abstract]
Antidilutive securities excluded from calculation of diluted earnings per share (in shares)	3,657,163	1,600,372

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS, Economic Dependency (Details) - USD ($)

12 Months Ended

Dec. 31, 2022

Dec. 31, 2021

Concentrations [Abstract]

Net product revenue

$ 49,521,923

$ 47,818,452

Accounts Receivable

6,536,415

11,441,107

Customer Concentration Risk [Member] | Customer 1 [Member]

Concentrations [Abstract]

Accounts Receivable

1,630,007

7,672,845

Customer Concentration Risk [Member] | Customer 2 [Member]

Concentrations [Abstract]

Accounts Receivable

2,062,431

^[1]

Customer Concentration Risk [Member] | Customer 3 [Member]

Concentrations [Abstract]

Accounts Receivable

1,433,305

^[1]

Supplier Concentration Risk [Member] | Vendor 1 [Member]

Concentrations [Abstract]

Accounts Payable

381,923

Supplier Concentration Risk [Member] | Vendor 2 [Member]

Concentrations [Abstract]

Accounts Payable

1,361,383

^[1]

Supplier Concentration Risk [Member] | Vendor 3 [Member]

Concentrations [Abstract]

Accounts Payable

179,482

353,097

Sales [Member] | Customer Concentration Risk [Member] | Customer 1 [Member]

Concentrations [Abstract]

Net product revenue

$ 18,050,287

$ 17,576,641

Percentage of net product sales

38.00%

51.00%

Sales [Member] | Customer Concentration Risk [Member] | Customer 2 [Member]

Concentrations [Abstract]

Net product revenue

$ 7,562,481

^[1]

Percentage of net product sales

16.00%

^[1]

Sales [Member] | Customer Concentration Risk [Member] | Customer 3 [Member]

Concentrations [Abstract]

Net product revenue

$ 3,606,552

^[1]

Percentage of net product sales

10.00%

^[1]

Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 1 [Member]

Concentrations [Abstract]

Percentage of net product sales

34.00%

Purchases

$ 5,359,388

Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 2 [Member]

Concentrations [Abstract]

Percentage of net product sales

16.00%

^[1]

Purchases

$ 3,163,285

^[1]

Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 3 [Member]

Concentrations [Abstract]

Percentage of net product sales

14.00%

10.00%

Purchases

$ 2,231,580

$ 2,031,795

[1]	In the tables above, an asterisk (*) indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, did not exceed 10% for the period indicated.

SUBSEQUENT EVENTS	12 Months Ended
SUBSEQUENT EVENTS	Dec. 31, 2022
SUBSEQUENT EVENTS [Abstract]
SUBSEQUENT EVENTS	NOTE 15 — SUBSEQUENT EVENTS: The Company entered into an Agreement and Plan of Merger (the “Merger Agreement”), dated as of January 31, 2023, with Biosynex SA, a French société anonyme (“Biosynex”), and Project Merci Merger Sub, Inc., a Nevada corporation and wholly-owned indirect subsidiary of Biosynex (the “Purchaser”). Pursuant to the Merger Agreement, on February 14, 2023, the Purchaser commenced a tender offer (the “Offer”) to purchase all of the issued and outstanding shares of the Company’s common stock, par value $0.01 per share (the “Shares”), for a purchase price of $0.45 per share, net to the seller in cash, without interest and subject to any required tax withholding. On March 15, 2023, Biosynex announced an extension of the Offer until 6:00 p.m., New York City time, on March 28, 2023. Subsequently, on March 29,2023, Biosynex announced an extension of the Offer until 6:00 p.m., New York City time, on April 12, 2023. If the conditions to the Offer are satisfied and the Offer closes, Purchaser would acquire all remaining Chembio shares by a merger of Purchaser with and into Chembio (the “Merger”), with Chembio surviving the Merger as a wholly-owned indirect subsidiary of Biosynex. At the effective time of the Merger (the “Effective Time”), each Share issued and outstanding immediately prior to the Effective Time (including shares paid to holders of vested Chembio restricted stock units) will be converted into the right to receive $0.45 per share. Stock options that are outstanding immediately prior to the Effective Time will automatically terminate for no consideration. If the conditions to the Offer are satisfied and the Offer closes, Purchaser would acquire all remaining Chembio shares by a merger of Purchaser with and into Chembio (the “Merger”), with Chembio surviving the Merger as a wholly-owned indirect subsidiary of Biosynex. At the effective time of the Merger (the “Effective Time”), each Share issued and outstanding immediately prior to the Effective Time (including shares paid to holders of vested Chembio restricted stock units) will be converted into the right to receive $0.45 per share. Stock options that are outstanding immediately prior to the Effective Time will automatically terminate for no consideration. The Merger Agreement and the transactions contemplated thereby, including the Merger, were unanimously approved by the Company’s Board of Directors. Completion of the Merger is subject to certain customary conditions as set forth in the Merger Agreement and the successful completion of the Offer. There can be no assurance that the Merger will be consummated on the terms described above or at all. The foregoing description of the Merger Agreement and the transactions contemplated thereby, including the Offer, does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Merger Agreement, which has been filed as Exhibit 2.1 to our Current Report on Form 8-K filed with the SEC on January 31, 2023.

INCOME TAXES (Details) - USD ($)	12 Months Ended			24 Months Ended
INCOME TAXES (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2003	Dec. 31, 2005
Components of (loss) before income taxes [Abstract]
United States operations	$ (18,425,426)	$ (26,858,325)
International operations	(4,830,826)	(7,107,254)
LOSS BEFORE INCOME TAXES BENEFIT	(23,256,252)	(33,965,579)
Current [Abstract]
Federal	0	0
State	33,948	7,891
Foreign	457	0
Total current (benefit) provision	34,405	7,891
Deferred [Abstract]
Federal	0	0
State	0	0
Foreign	0	(69,941)
Total deferred (benefit) provision	0	(69,941)
Total (benefit) provision	$ 34,405	$ (62,050)
Taxes [Abstract]
Federal income tax at statutory rates	21.00%	21.00%
State income taxes, net of federal benefit	0.01%	0.18%
Nondeductible expenses	(3.69%)	(2.04%)
Foreign rate differential	0.40%	0.32%
Change in valuation allowance	(16.85%)	(19.60%)
Other	(1.02%)	0.32%
Income tax (expense) benefit	(0.15%)	0.18%
Income Taxes [Abstract]
Net operating losses			$ 5,832,516	$ 8,586,861
Annual limitation			150,608	1,111,831
Built-in-gains of net operating losses			$ 488,207	$ 1,756,842
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, subject to expiration	$ 25,671,216
Operating loss carryforwards, not subject to expiration	66,924,161
Components of Deferred Tax Assets and Liabilities [Abstract] [Abstract]
Inventory reserves	343,262	$ 333,551
Accrued expenses	822,145	374,673
Net operating loss carry-forwards	22,123,522	20,401,828
Research and development credit	1,632,846	1,651,529
Research and development expenses	628,711	0
Stock-based compensation	437,992	259,106
Interest Expense	1,825,347	1,221,171
Lease obligations	1,381,089	1,504,433
Intangibles	136,478	137,142
Total deferred tax assets	29,331,392	25,883,433
Right-of-use assets	(1,155,407)	(1,294,519)
Depreciation	(252,097)	(560,754)
Total deferred tax liabilities	(1,407,504)	(1,855,273)
Net deferred tax assets before valuation allowance	27,923,888	24,028,160
Less valuation allowances	(27,923,888)	(24,028,160)
Net noncurrent deferred tax liabilities	0	$ 0
Unremitted earnings of foreign subsidiaries	0
State [Member]
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, subject to expiration	4,746,769
Foreign [Member]
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, subject to expiration	5,803,963
Operating loss carryforwards, not subject to expiration	$ 3,207,825

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS, Stockholder Litigation (Details)			12 Months Ended
	Mar. 02, 2023 USD ($)	Feb. 03, 2023 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2020 Lawsuit
Stockholder Litigation [Abstract]
Number of class action lawsuits \| Lawsuit				4
Maximum [Member]
Stockholder Litigation [Abstract]
Attorneys' fees			$ 595,000
Subsequent Event [Member]
Litigation Settlement [Abstract]
One time civil monetary penalty paid to SEC	$ 500,000
Stockholder Litigation [Abstract]
Payment to settlement escrow account		$ 8,100,000
Litigation amount to be paid		$ 209,000

SUBSEQUENT EVENTS (Details) - $ / shares	Jan. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Business Combination, Description [Abstract]
Common stock, par value (in dollars per share)		$ 0.01	$ 0.01
Subsequent Event [Member] \| Biosynex SA [Member]
Business Combination, Description [Abstract]
Common stock, par value (in dollars per share)	$ 0.01
Business acquisition share price (in dollars per share)	$ 0.45

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Tables)

12 Months Ended

Dec. 31, 2022

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract]

Future Minimum Salary Commitment

The Company has contracts with three key employees. The following table is a schedule of future minimum salary commitments:

2023		$	1,178,000
2024			383,000

Components of Lease Expense

The components of lease expense were as follows:

	Year Ended December 31, 2022		Year Ended December 31, 2021
Operating lease expense	$	1,630,609	$	1,625,280

Finance lease cost
Amortization of right-of-use assets	$	71,129	$	66,872
Interest on lease liabilities		17,015		20,077
Total finance lease expense	$	88,144	$	86,949

Supplemental Cash Flow and Other Information Related to Leases

Supplemental cash flow and other information related to leases were as follows:

	Year Ended December 31, 2022		Year Ended December 31, 2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases	$	1,453,778	$	1,404,532
Operating cash flows for finance leases		17,015		20,077
Financing cash flows for finance leases		70,514		61,867
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	717,956	$	-
Finance leases		16,234		25,609

Supplemental Balance Sheet Information Related to Leases

Supplemental balance sheet information related to leases was as follows:

	December 31, 2022			December 31, 2021
Finance Leases
Finance lease right of use asset	$	356,997		$	340,762
Accumulated depreciation		(220,021	)		(148,892	)
Finance lease right of use asset, net	$	136,976		$	191,870

Current portion of finance lease liability		76,869			68,176
Finance lease liability, net of current		76,705			139,678
Total finance lease liabilities	$	153,574		$	207,854

Weighted Average Remaining Lease Term
Operating leases	6.6 years			7.5 years
Finance leases	2.1 years			2.9 years

Weighted Average Discount Rate
Operating leases		8.70	%		8.08	%
Finance leases		9.18	%		8.76	%

Maturities of Lease Liabilities

Maturities of lease liabilities as of December 31 were as follows:

	December 31, 2022						December 31, 2021
	Operating Leases			Finance Leases			Operating Leases			Finance Leases
2023	$	1,428,821		$	87,884		$	1,447,249		$	83,624
2024		1,220,150			60,116			1,221,017			83,624
2025		1,049,442			16,731			1,018,875			55,856
2026		1,080,925			5,940			1,049,442			12,471
2027		1,113,353			355			1,080,925			1,680
Thereafter		2,530,168			-			3,643,520			-
Total lease payments	$	8,422,859		$	171,026		$	9,461,028		$	237,255
Less: imputed interest		(2,081,972	)		(17,452	)		(2,598,583	)		(29,401	)
Total	$	6,340,887		$	153,574		$	6,862,445		$	207,854

Customer and Purchase Concentration Risks

The following table discloses product sales the Company had to customers that purchased in excess of 10% of the Company’s net product sales for the periods indicated:

	For The Years Ended										Accounts Receivable
	December 31, 2022					December 31, 2021					December 31, 2022		December 31, 2021
	Net Product Sales		% of Net Product Sales			Net Product Sales		% of Net Product Sales
Customer 1	$	18,050,287		38	%	$	17,576,641		51	%	$	1,630,007	$	7,672,845
Customer 2		7,562,481		16	%		*		*			2,062,431		*
Customer 3		*		*			3,606,552		10	%		*		1,433,305.00

Revenue includes product sales only, while accounts receivable reflects the total due from the customer, including freight.

The following table discloses purchases the Company made from vendors in excess of 10% of the Company’s net purchases for the periods indicated:

	For The Years Ended										Accounts Payable
	December 31, 2022					December 31, 2021					December 31, 2022		December 31, 2021
	Purchases		% of Purc.			Purchases		% of Purc.
Vendor 1	$	5,359,388		34	%	$	*		*		$	381,923	$	–
Vendor 2	$	*		*		$	3,163,285		16	%	$	*	$	1,361,383
Vendor 3	$	2,231,580		14	%	$	2,031,795		10	%	$	179,482	$	353,097

In the tables above, an asterisk (*) indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, did not exceed 10% for the period indicated.

FIXED ASSETS

12 Months Ended

Dec. 31, 2022

FIXED ASSETS [Abstract]

FIXED ASSETS

NOTE 4 — FIXED ASSETS:

Fixed assets consist of the following at December 31:

	December 31
	2022			2021
Machinery and Equipment	$	13,848,792		$	12,500,235
Furniture and Fixtures		11,996			6,631
Computer Equipment		468,185			465,576
Leasehold Improvements		3,027,861			2,933,159
Enterprise Business Systems		2,953,221			2,953,221
Subtotal:		20,310,055			18,858,822
Less: Accumulated Depreciation and Amortization		(12,155,404	)		(10,302,049	)
	$	8,154,651		$	8,556,773

Depreciation expense for the 2022 and 2021 years totaled $1.9 million and $1.8 million, respectively.

Effective May 2021, the Company discontinued its operations in Malaysia. Impairment charges recorded for the Malaysian fixed assets, net for the year ended December 31, 2022 and 2021 were $0 and $0.1 million, respectively.

As of December 31, 2022 and 2021, the Company has purchased manufacturing equipment that is not yet in use and therefore has not been depreciated, aggregating $3,192,824 and $1,970,652, respectively. These balances are reflected under the Machinery and Equipment line on the table above.

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2022

INCOME TAXES [Abstract]

Components of (Loss) Before Income Taxes

The components of loss before income taxes consisted of the following:

	Year Ending December 31,
	2022			2021
United States operations	$	(18,425,426	)	$	(26,858,325	)
International operations		(4,830,826	)		(7,107,254	)
Loss before taxes	$	(23,256,252	)	$	(33,965,579	)

(Benefit) Provision for Income Taxes

The (benefit) provision for income taxes for the years ended December 31, 2022 and 2021 was comprised of the following:

	Year Ending December 31,
	2022		2021
Current
Federal	$	-	$	-
State		33,948		7,891
Foreign		457		-
Total current (benefit) provision		34,405		7,891

Deferred
Federal		-		-
State		-		-
Foreign		-		(69,941	)
Total deferred (benefit) provision		-		(69,941	)

Total (benefit) provision	$	34,405	$	(62,050	)

Reconciliation of Federal Statutory Rate to Effective Rate Applicable to Loss Before Income Taxes

A reconciliation of the Federal statutory rate to the effective rate applicable to loss before income taxes is as follows:

	Year Ending December 31,
	2022			2021
Federal income tax at statutory rates		21.00	%		21.00	%
State income taxes, net of federal benefit		0.01	%		0.18	%
Nondeductible expenses		(3.69	)%		(2.04	)%
Foreign rate differential		0.40	%		0.32	%
Change in valuation allowance		(16.85	)%		(19.60	)%
Other		(1.02	)%		0.32	%
Income tax (expense) benefit		(0.15	)%		0.18	%

Deferred Tax Assets and Liabilities

Deferred tax assets and liabilities as of December 31 are as follows:

	Year Ending December 31,
	2022			2021
Inventory reserves	$	343,262		$	333,551
Accrued expenses		822,145			374,673
Net operating loss carry-forwards		22,123,522			20,401,828
Research and development credit		1,632,846			1,651,529
Research and development expenses		628,711			-
Stock-based compensation		437,992			259,106
Interest Expense		1,825,347			1,221,171
Lease obligations		1,381,089			1,504,433
Intangibles		136,478			137,142
Total deferred tax assets		29,331,392			25,883,433

Right-of-use assets		(1,155,407	)		(1,294,519	)
Depreciation		(252,097	)		(560,754	)
Total deferred tax liabilities		(1,407,504	)		(1,855,273	)

Net deferred tax assets before valuation allowance		27,923,888			24,028,160
Less valuation allowances		(27,923,888	)		(24,028,160	)
Net noncurrent deferred tax liabilities	$	-		$	-

EQUITY INCENTIVE PLANS (Tables)

12 Months Ended

Dec. 31, 2022

EQUITY INCENTIVE PLANS [Abstract]

Assumptions Made in Calculating Fair Values of Options

The weighted-average assumptions made in calculating the fair values of options are as follows for the respective years ended December 31:

	2022			2021
Expected term (in years)		6.00			5.10
Expected volatility		91.62	%		78.95	%
Expected dividend yield		0			0
Risk-free interest rate		1.97	%		0.85	%

Stock Option Activity

The following table provides stock option activity for the years ended December 31, 2022:

	Number of Shares	Weighted Average Exercise Price per Share		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at December 31, 2021	1,600,372	$	4.18	6.59 years	$	-

Granted	2,481,968	$	1.24			-
Exercised	—	$	—			-
Forfeited	154,076	$	2.70			-
Expired/cancelled	271,101		5.01
Outstanding at December 31, 2022	3,657,163	$	2.20	8.05 years	$	-

Exercisable at December 31, 2022	581,574	$	3.98	5.42 years	$	-

Stock Options Outstanding

The following table summarizes information about stock options outstanding at December 31, 2022:

	Stock Options Outstanding								Stock Options Exercisable
Range of Exercise Prices	Shares Outstanding		Average Remaining Contract Life (Year)		Weighted Average Exercise Price		Aggregate Intrinsic Value		Shares Exercisable		Weighted Average Exercise Price		Aggregate Intrinsic Value
1 to 2.79999		2,824,519		8.26	$	1.40	$	-		266,431	$	2.36	$	-
2.8 to 4.59999		26,335		8.43		3.06		-		8,776		3.06		-
4.6 to 6.39999		759,434		7.69		4.80		-		259,492		4.93		-
6.4 to 8.19999		46,875		0.36		8.15		-		46,875		8.15		-
Total		3,657,163		8.04	$	2.20	$	-		581,574	$	3.98	$	-

Summary of Restricted Stock and Restricted Stock Units Outstanding

The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2022:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Unvested at December 31, 2021		705,325	$	3.34

Granted		1,308,547		0.75
Vested		203,839		3.75
Forfeited/expired/cancelled		221,646		1.35
Unvested at December 31, 2022		1,588,387		1.34

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

12 Months Ended

Dec. 31, 2022

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

NOTE 11 — GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY:

	Year Ending December 31,
	2022		2021
Africa	$	7,000,085	$	5,562,787
Asia		626,210		664,579
Europe & Middle East		3,351,003		4,067,682
Latin America		19,253,504		18,418,983
United States		16,860,871		6,023,413
	$	47,091,673	$	34,737,444

Property, plant and equipment, net by geographic area are as follows:

	2022		2021
Asia	$	81,536	$	86,041
Europe & Middle East		74,815		113,883
Latin America		81,315		36,224
United States		7,916,985		8,320,625
	$	8,154,651	$	8,556,773

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8924-108599

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+ Details

GOODWILL AND INTANGIBLE ASSETS (Tables)

12 Months Ended

Dec. 31, 2022

GOODWILL AND INTANGIBLE ASSETS [Abstract]

Changes in Goodwill

Following is a table that reflects changes in Goodwill:

Beginning balance January 1, 2022	$	3,022,787
Changes in foreign currency exchange rate		10,778
Impairment		(3,033,565	)
Balance at December 31, 2022	$	—

Intangible Assets

Intangible assets consist of the following at:

			December 31, 2022								December 31, 2021
	Weighted Average Remaining Life		Cost		Accumulated Amortization		Impairment		Net Book Value		Cost		Accumulated Amortization		Impairment		Net Book Value
Intellectual property		-	$	-	$	-	$	-	$	-	$	1,636,724	$	546,252		1,090,472	$	-
Developed technology		-		-		-		-		-		1,944,500		828,681		1,115,819		-
Customer contracts/relationships		-		-		-		-		-		1,254,344		477,661		776,683		-
Trade names		-		-		-		-		-		110,853		43,696		67,157		-
			$	-	$	-	$	-	$	-	$	4,946,421	$	1,896,290		3,050,131	$	-

- Definition

Tabular disclosure of goodwill by reportable segment and in total which includes a rollforward schedule.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
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+ Details

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	Dec. 31, 2022	Dec. 31, 2021
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract]
Net loss	$ (23,290,657)	$ (33,903,529)
Other comprehensive loss:
Foreign currency translation adjustments	255,085	(501,456)
COMPREHENSIVE LOSS	$ (23,035,572)	$ (34,404,985)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS, Restructuring Costs and Impairment Charges (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2022	Dec. 31, 2021
IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS [Abstract]
Severance		$ 202,621	$ 83,087
Restructuring costs		0	1,083,951
Impairment	$ 3,000,000	3,033,565	5,880,741
Total costs		$ 3,236,186	$ 7,047,779

EQUITY INCENTIVE PLANS, Summary (Details) - USD ($)			12 Months Ended
EQUITY INCENTIVE PLANS, Summary (Details) - USD ($)	Jun. 25, 2021	Jan. 03, 2020	Dec. 31, 2022	Dec. 31, 2021	Jun. 19, 2014
Stock options, additional disclosure [Abstract]
Outstanding, aggregate intrinsic value, end of period			$ 0
Exercisable, aggregate intrinsic value, end of period			$ 0
Total fair value of stock options vested during period		$ 943,126
Stock Options [Member]
Assumptions made in calculating fair values of options [Abstract]
Expected term			6 years	5 years 1 month 6 days
Expected volatility			91.62%	78.95%
Expected dividend yield			0.00%	0.00%
Risk-free interest rate			1.97%	0.85%
Stock options, number of shares [Roll forward]
Outstanding, beginning of period (in shares)			1,600,372
Granted (in shares)			2,481,968
Exercised (in shares)			0
Forfeited (in shares)			154,076
Expired/cancelled (in shares)			271,101
Outstanding, end of period (in shares)			3,657,163	1,600,372
Exercisable, end of period (in shares)			581,574
Stock options, weighted average exercise price per share [Roll Forward]
Outstanding, beginning of period (in dollars per share)			$ 4.18
Granted (in dollars per share)			1.24
Exercised (in dollars per share)			0
Forfeited (in dollars per share)			2.7
Expired/cancelled (in dollars per share)			5.01
Outstanding, end of period (in dollars per share)			2.2	$ 4.18
Exercisable, end of period (in dollars per share)			$ 3.98
Stock options, additional disclosure [Abstract]
Outstanding, weighted average remaining contract term			8 years 18 days	6 years 7 months 2 days
Exercisable, weighted average remaining contract term			5 years 5 months 1 day
Outstanding, aggregate intrinsic value, beginning of period			$ 0
Granted, aggregate intrinsic value			0
Exercised, aggregate intrinsic value			0
Forfeited, aggregate intrinsic value			0
Outstanding, aggregate intrinsic value, end of period			0	$ 0
Exercisable, aggregate intrinsic value, end of period			0
Net unrecognized compensation cost			$ 2,113,275
Weighted average period for recognition of net unrecognized compensation cost			2 years 7 months 9 days
Total fair value of stock options vested during period			$ 962,801
2014 Stock Incentive Plan [Member] \| Stock Options [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of shares authorized under the plan (in shares)					800,000
Number of stock options expired, forfeited or exercised under the plan (in shares)			732,064
Number of shares not issued (in shares)			21,061
Options still available to be issued (in shares)			0
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)			46,875
2019 Omnibus Incentive Plan [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of stock options expired, forfeited or exercised under the plan (in shares)			1,307,361
Options still available to be issued (in shares)			226,702
Stock options, number of shares [Roll forward]
Outstanding, end of period (in shares)			4,660,098
2019 Omnibus Incentive Plan [Member] \| Stock Options [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of shares authorized under the plan (in shares)	4,800,000		2,400,000
Increase in number of shares authorized (in shares)	2,400,000

SIGNIFICANT ACCOUNTING POLICIES, Leases (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Leases [Abstract]
Percentage of minimum lease payment for fair value	90.00%
Lease term	12 months
Malaysia [Member]
Leases [Abstract]
Lease impairment charges	$ 0.0	$ 0.1

IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS (Tables)

12 Months Ended

Dec. 31, 2022

IMPAIRMENT, RESTRUCTURING, SEVERANCE AND RELATED COSTS [Abstract]

Total Costs

The table below represents the total costs by category:

	For the year ended December 31, 2022		For the year ended December 31, 2021
Severance	$	202,621	$	83,087
Restructuring costs		-		1,083,951
Impairment		3,033,565		5,880,741
	$	3,236,186	$	7,047,779

FIXED ASSETS (Tables)

12 Months Ended

Dec. 31, 2022

FIXED ASSETS [Abstract]

Fixed Assets

Fixed assets consist of the following at December 31:

	December 31
	2022			2021
Machinery and Equipment	$	13,848,792		$	12,500,235
Furniture and Fixtures		11,996			6,631
Computer Equipment		468,185			465,576
Leasehold Improvements		3,027,861			2,933,159
Enterprise Business Systems		2,953,221			2,953,221
Subtotal:		20,310,055			18,858,822
Less: Accumulated Depreciation and Amortization		(12,155,404	)		(10,302,049	)
	$	8,154,651		$	8,556,773

STOCKHOLDERS' EQUITY (Details) - USD ($)		12 Months Ended
STOCKHOLDERS' EQUITY (Details) - USD ($)	Jul. 19, 2021	Dec. 31, 2022	Dec. 31, 2021	Nov. 04, 2021
Common Stock [Abstract]
Gross proceeds from issuance of common stock		$ 4,311,486	$ 38,811,958
Preferred Stock [Abstract]
Preferred stock - shares authorized (in shares)		10,000,000	10,000,000
Preferred stock - shares outstanding (in shares)		0	0
Treasury Stock, Shares [Abstract]
Treasury stock, shares (in shares)		48,057	48,057
Common Stock [Member]
Common Stock [Abstract]
Number of shares issued (in shares)	6,466,191
Volume-weighted average price per share (in dollars per share)				$ 0.71
Gross proceeds from issuance of common stock	$ 4,600,000
Net proceeds from issuance of common stock after deduction of placement fee and other transactions costs	4,300,000
Common Stock [Member] \| Maximum [Member]
Common Stock [Abstract]
Gross proceeds from additional shares of common stock that may be issued and sold	6,300,000
ATM Offering [Member] \| Craig-Hallum [Member] \| Maximum [Member]
Common Stock [Abstract]
Aggregate shares of common stock sold	$ 60,000,000

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS, Leases (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Components of Lease Expense [Abstract]
Operating lease expense	$ 1,630,609	$ 1,625,280
Finance lease cost [Abstract]
Amortization of right-of-use assets	71,129	66,872
Interest on lease liabilities	17,015	20,077
Total finance lease expense	88,144	86,949
Cash paid for amounts included in the measurement of lease liabilities [Abstract]
Operating cash flows for operating leases	1,453,778	1,404,532
Operating cash flows for finance leases	17,015	20,077
Financing cash flows for finance leases	70,514	61,867
Right-of-use assets obtained in exchange for lease obligations [Abstract]
Operating leases	717,956	0
Finance leases	16,234	25,609
Finance Leases [Abstract]
Finance lease right-of-use asset	356,997	340,762
Accumulated depreciation	(220,021)	(148,892)
Finance lease right-of-use asset, net	136,976	191,870
Finance Lease Liability [Abstract]
Current portion of finance lease liability	76,869	68,176
Finance lease liability, net of current	76,705	139,678
Total finance lease liabilities	$ 153,574	$ 207,854
Weighted Average Remaining Lease Term [Abstract]
Operating leases	6 years 7 months 6 days	7 years 6 months
Finance leases	2 years 1 month 6 days	2 years 10 months 24 days
Weighted Average Discount Rate [Abstract]
Operating leases	8.70%	8.08%
Finance leases	9.18%	8.76%
Maturities of Operating Lease Liabilities [Abstract]
2023	$ 1,428,821	$ 1,447,249
2024	1,220,150	1,221,017
2025	1,049,442	1,018,875
2026	1,080,925	1,049,442
2027	1,113,353	1,080,925
Thereafter	2,530,168	3,643,520
Total lease payments	8,422,859	9,461,028
Less: imputed interest	(2,081,972)	(2,598,583)
Total	6,340,887	6,862,445
Maturities of Finance Lease Liabilities [Abstract]
2023	87,884	83,624
2024	60,116	83,624
2025	16,731	55,856
2026	5,940	12,471
2026	355	1,680
Thereafter	0	0
Total lease payments	171,026	237,255
Less: imputed interest	(17,452)	(29,401)
Total	$ 153,574	$ 207,854

EQUITY INCENTIVE PLANS, One-Time Incentive Bonuses (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Aug. 31, 2021	Dec. 31, 2022	Dec. 31, 2021
EQUITY INCENTIVE PLANS [Abstract]
Amount made available for cash awards	$ 1.5
Payments made by the company		$ 0.6	$ 0.1

FIXED ASSETS (Details) - USD ($)	12 Months Ended
FIXED ASSETS (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Summary of fixed assets [Abstract]
Fixed assets, gross	$ 20,310,055	$ 18,858,822
Less: Accumulated Depreciation and Amortization	(12,155,404)	(10,302,049)
Fixed assets, net	8,154,651	8,556,773
Depreciation expense	1,900,000	1,800,000
Malaysia [Member]
Summary of fixed assets [Abstract]
Impairment charges of fixed assets	0	100,000
Machinery and Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	13,848,792	12,500,235
Furniture and Fixtures [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	11,996	6,631
Computer Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	468,185	465,576
Leasehold Improvements [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	3,027,861	2,933,159
Enterprise Business Systems [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	2,953,221	2,953,221
Manufacturing Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	$ 3,192,824	$ 1,970,652

INVENTORIES (Details) - USD ($)	12 Months Ended
INVENTORIES (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Net Inventories [Abstract]
Raw Materials	$ 4,539,346	$ 7,306,095
Work in Process	1,106,962	3,556,878
Finished Goods	2,069,105	2,057,478
Inventories	7,715,413	12,920,451
Charge related to write-down of inventory	$ 569,430	$ 4,054,701