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Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2018	Mar. 01, 2019	Jun. 29, 2018
Document and Entity Information [Abstract]
Entity Registrant Name	Chembio Diagnostics, Inc.
Entity Central Index Key	0001092662
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Ex Transition Period	false
Entity Public Float			$ 154,594,062
Entity Common Stock, Shares Outstanding		17,166,459
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2018
Document Fiscal Year Focus	2018
Document Fiscal Period Focus	FY

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2018	Dec. 31, 2017
CURRENT ASSETS:
Cash and cash equivalents	$ 12,524,551	$ 3,790,302
Accounts receivable, net of allowance for doubtful accounts of $42,000 at December 31, 2018 and 2017, respectively	7,373,971	2,085,340
Inventories, net	7,851,222	4,423,618
Prepaid expenses and other current assets	702,010	554,383
TOTAL CURRENT ASSETS	28,451,754	10,853,643
FIXED ASSETS, net of accumulated depreciation	2,873,920	1,909,232
OTHER ASSETS:
Intangible assets, net	3,884,831	1,597,377
Goodwill	4,983,127	1,666,610
Deposits and other assets	717,551	589,159
TOTAL ASSETS	40,911,183	16,616,021
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	5,888,681	3,046,303
Deferred revenue	422,905	50,000
Current portion of note payable	207,694	0
TOTAL CURRENT LIABILITIES	6,519,280	3,096,303
OTHER LIABILITIES:
Notes payable	171,821	99,480
Deferred tax liability	892,308	341,042
TOTAL LIABILITIES	7,583,409	3,536,825
COMMITMENTS AND CONTINGENCIES (Note 13)
STOCKHOLDERS' EQUITY:
Preferred stock - 10,000,000 shares authorized; none outstanding	0	0
Common stock - $.01 par value; 100,000,000 shares authorized, 17,166,459 and 12,318,570 shares issued and outstanding at December 31, 2018 and 2017, respectively	171,664	123,185
Additional paid-in capital	90,953,788	62,821,288
Accumulated deficit	(57,909,874)	(50,044,225)
Accumulated other comprehensive income	112,196	178,948
TOTAL STOCKHOLDERS' EQUITY	33,327,774	13,079,196
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 40,911,183	$ 16,616,021

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
CURRENT ASSETS:
Accounts receivable, allowance for doubtful accounts	$ 42,000	$ 42,000
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)	17,166,459	12,318,570
Common stock, shares outstanding (in shares)	17,166,459	12,318,570

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2018	Dec. 31, 2017
REVENUES:
TOTAL REVENUES	$ 33,409,251	$ 24,015,427
COSTS AND EXPENSES:
Cost of product sales	21,427,243	12,921,157
Research and development expenses	8,526,256	8,555,381
Selling, general and administrative expenses	11,100,775	8,963,363
Acquisition costs	337,645	58,076
TOTAL OPERATING EXPENSES	41,391,919	30,497,977
LOSS FROM OPERATIONS	(7,982,668)	(6,482,550)
OTHER INCOME (EXPENSE):
Interest income, net	49,498	22,485
LOSS BEFORE INCOME TAXES (BENEFIT) PROVISION	(7,933,170)	(6,460,065)
Income tax (benefit) provision	(67,521)	(88,305)
NET LOSS	$ (7,865,649)	$ (6,371,760)
Basic loss per share (in dollars per share)	$ (0.55)	$ (0.52)
Diluted loss per share (in dollars per share)	$ (0.55)	$ (0.52)
Weighted average number of shares outstanding, basic (in shares)	14,432,505	12,300,031
Weighted average number of shares outstanding, diluted (in shares)	14,432,505	12,300,031
Net Product Sales [Member]
REVENUES:
TOTAL REVENUES	$ 26,741,020	$ 19,322,302
License and Royalty Revenue [Member]
REVENUES:
TOTAL REVENUES	948,773	741,534
R&D and Grant Revenue [Member]
REVENUES:
TOTAL REVENUES	$ 5,719,458	$ 3,951,591

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)	Dec. 31, 2018	Dec. 31, 2017
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract]
Net loss	$ (7,865,649)	$ (6,371,760)
Other comprehensive income:
Foreign currency translation adjustments	(66,752)	178,948
COMPREHENSIVE LOSS	$ (7,932,401)	$ (6,192,812)

- Definition

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

+ References + Details

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	Common Stock [Member]	Additional Paid-in-Capital [Member]	Accumulated Deficit [Member]	AOCI [Member]	Total
Balance at Dec. 31, 2016	$ 120,268	$ 60,721,783	$ (43,672,465)	$ 0	$ 17,169,586
Balance (in shares) at Dec. 31, 2016	12,026,847
Common Stock:
Purchase of RVR Diagnostics Sdn Bhd	$ 2,692	1,680,033	0	0	1,682,725
Purchase of RVR Diagnostics Sdn Bhd (in shares)	269,236
Options:
Exercised	$ 225	34,575	0	0	$ 34,800
Exercised (in shares)	22,487				22,487
Stock option compensation	$ 0	384,897	0	0	$ 384,897
Comprehensive income (loss)	0	0	0	178,948	178,948
Net loss	0	0	(6,371,760)	0	(6,371,760)
Balance at Dec. 31, 2017	$ 123,185	62,821,288	(50,044,225)	178,948	13,079,196
Balance (in shares) at Dec. 31, 2017	12,318,570
Common Stock:
New stock from offerings	$ 45,098	27,431,162	0	0	27,476,260
New stock from offerings (in shares)	4,509,760
Restricted stock issued	$ 2,668	(2,668)	0	0	0
Restricted stock issued (in shares)	266,839
Restricted stock compensation	$ 0	281,249	0	0	281,249
Options:
Exercised	$ 713	71,201	0	0	$ 71,914
Exercised (in shares)	71,290				71,290
Stock option compensation	$ 0	351,556	0	0	$ 351,556
Comprehensive income (loss)	0	0	0	(66,752)	(66,752)
Net loss	0	0	(7,865,649)	0	(7,865,649)
Balance at Dec. 31, 2018	$ 171,664	$ 90,953,788	$ (57,909,874)	$ 112,196	$ 33,327,774
Balance (in shares) at Dec. 31, 2018	17,166,459

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2018	Dec. 31, 2017
CASH FLOWS FROM OPERATING ACTIVITIES:
Cash received from customers and grants	$ 28,632,084	$ 24,971,299
Cash paid to suppliers and employees	(40,452,110)	(30,028,299)
Income taxes paid	(10,913)	0
Interest received, net	69,930	22,485
Interest paid	(20,432)	0
Net cash used in operating activities	(11,781,441)	(5,034,515)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of opTricon GmbH, net of cash acquired	(5,491,204)	0
Purchase of RVR Diagnostics Sdn Bhd, net of cash acquired	0	(850,000)
Acquisition of and deposits on fixed assets	(1,467,192)	(1,026,954)
Net cash used in investing activities	(6,958,396)	(1,876,954)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from option exercises	71,914	34,800
Proceeds from note payable	0	99,480
Payments on note payable	(64,481)	0
Proceeds from sale of common stock, net	27,476,260	0
Net cash provided by financing activities	27,483,693	134,280
Effect of exchange rate changes on cash	(9,607)	13,027
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	8,734,249	(6,764,162)
Cash and cash equivalents - beginning of the period	3,790,302	10,554,464
Cash and cash equivalents - end of the period	12,524,551	3,790,302
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES
Net loss	(7,865,649)	(6,371,760)
Adjustments:
Depreciation and amortization	902,505	1,276,963
Fair value adjustment to contingent consideration	0	(148,000)
Share based compensation	632,805	384,897
Change in deferred tax assets	(78,432)	0
Changes in assets and liabilities, net of effects from purchase of opTricon GmbH:
Accounts receivable	(5,150,072)	1,298,389
Inventories	(3,077,104)	(1,088,430)
Prepaid expenses and other current assets	(118,293)	285,762
Deposits and other assets	0	(512,272)
Accounts payable and accrued liabilities	2,599,894	182,453
Deferred revenue	372,905	(342,517)
Net cash used in operating activities	(11,781,441)	(5,034,515)
Supplemental disclosures for non-cash investing and financing activities:
Deposits on manufacturing equipment transferred to fixed assets	257,455	174,399
Deposits and other assets transferred to intangible assets	118,899	0
Seller-financed equipment purchases	326,110	0
Accrual of contingent earn-out	0	148,000
Issuance of common stock for net assets of business acquired	$ 0	$ 1,682,725

DESCRIPTION OF BUSINESS	12 Months Ended
DESCRIPTION OF BUSINESS	Dec. 31, 2018
DESCRIPTION OF BUSINESS [Abstract]
DESCRIPTION OF BUSINESS	NOTE 1 — DESCRIPTION OF BUSINESS: Chembio Diagnostics, Inc. and its subsidiaries (collectively, the “Company” or “Chembio”), develop, manufacture, and commercialize point-of-care diagnostic tests that are used to detect and diagnose diseases. The Company is pursuing three corporate priorities: (1) expand its commercialization, (2) advance its research and development pipeline, and (3) prepare for future growth. All products that are currently being developed are based on the Company’s patented DPP^® technology, a novel point-of-care diagnostic platform that offers certain customer advantages as compared to traditional lateral flow technology. The Company’s product commercialization and product development efforts are focused on infectious disease testing and technology collaborations. In infectious disease, the Company is commercializing tests for HIV and Syphilis, Zika virus, and developing tests for malaria, dengue virus, chikungunya virus, ebola, lassa, Marburg, leptospirosis, Rickettsia typhi, Burkholderia pseudomallei, and Orientia tsutsugamushi, individually or as part of fever panel tests. Through technology collaborations, the Company is developing tests for a specific form of cancer, concussion, bovine tuberculosis, and for eosinophilic respiratory disease, the latter in collaboration with global biopharmaceutical company AstraZeneca. Large and growing markets have been established for these kinds of tests, initially in high prevalence regions where they are indispensable for large scale prevention and treatment programs. More generally, the Company believes there is and will continue to be a growing demand for diagnostic products that can provide accurate, actionable diagnostic information in a rapid, cost-effective manner at the point of care. The Company’s products are sold to medical laboratories and hospitals, governmental and public health entities, non-governmental organizations, medical professionals and retail establishments, both domestically and internationally, under the Company’s STAT PAK^®, SURE CHECK^®, STAT-VIEW^® or DPP^® registered trademarks, or under the private labels of the Company’s marketing partners. The Company routinely enters into arrangements with governmental and non-governmental organizations for the funding of certain research and development efforts.

ACQUISITIONS

12 Months Ended

Dec. 31, 2018

ACQUISITIONS [Abstract]

ACQUISITIONS

NOTE 2 — ACQUISITIONS:

opTricon

On November 6, 2018, pursuant to a share purchase agreement, the Company acquired all of the outstanding shares of opTricon GmbH (“opTricon”), a privately-held Germany based developer and manufacturer of handheld analyzers for rapid diagnostic tests, for $5.5 million in cash, subject to routine post-closing adjustments. Since 2015, the Company and opTricon have been parties to an agreement under which the Company has collaborated in developing its DPP Micro Reader, a handheld, battery-operated analyzer that uses an innovative image sensor to provide, when combined with the Company’s DPP tests, a quantitative interpretation of diagnostic results. The Company purchased opTricon because it believes it will enable it to promote DPP tests and DPP Micro Reader more actively across global markets. The results of opTricon operations have been reflected in the consolidated financial statements since November 6, 2018.

As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $3,337,000 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $2,260,000 in intangible assets associated with the addition of opTricon’s developed technology and customer base. The Consolidated Statements of Operations for the year ended December 31, 2018 include $337,645 of transaction costs related to the opTricon acquisition.

The acquisition was accounted for using the purchase method of accounting. The following table summarizes the preliminary allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of November 6, 2018:


	Amount
Net current assets	$	404,204
Property, plant and equipment		125,000
Goodwill		3,337,000
Deferred tax liability		(635,000	)
Other intangible assets (estimated useful life):
Developed technology (7 years)		1,900,000
Customer contracts / relationships (10 years)		360,000
Total consideration	$	5,491,204

The Company calculated the fair value of the fixed assets based on the net book value of opTricon as that approximates fair value. The developed technology and customer contracts/relationships were based on discounted cash flows using management estimates.

As indicated, the allocation of the purchase price shown above is preliminary, pending completion of an analysis of the deferred tax liability. Therefore, an adjustment may be required.

The following represents unaudited pro forma operating results for the year ended December 31, 2018 as if the operations of opTricon had been included in the Company’s Consolidated Statements of Operations as of January 1, 2018:

	Proforma
	December 31, 2018
Total revenues	$	35,442,806

Net loss		(8,394,074	)

Net loss per common share	$	(0.58	)

Diluted net loss per common share	$	(0.58	)

The pro forma financial information includes business combination accounting effects from the acquisition including amortization charges from acquired intangible assets of opTricon approximately $351,000 for the year ended December 31, 2018. The unaudited pro forma information as presented above is for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisition had taken place at the beginning of fiscal 2018. Included in the proforma table above are opTricon's net revenues and pre-tax loss for the year ended December 31, 2018 which were approximately $2,214,000 and $213,000, respectively. opTricon's results of operations from the date of acquisition through December 31, 2018 are immaterial to the Company's Consolidated Statements of Operations.

RVR Diagnostics

On January 9, 2017, pursuant to a stock purchase agreement (the "Stock Purchase Agreement), the Company acquired all of the outstanding common stock of RVR Diagnostics Sdn Bhd ("RVR"), a privately-held Malaysia based manufacturing company focused on assembly and sales of rapid medical assays, for $3,231,000. The Company acquired RVR, which subsequently changed its name to Chembio Diagnostics Malaysia Sdn Bhd ("CDM"), to have a better presence in Asia, access to lower cost, shorter approval time of in-country regulatory approvals, and a lower cost assembly operation.

Total consideration was: (i) a cash payment of $1,400,000, of which $550,000 was paid as a deposit in December 2016; (ii) 269,236 shares of Chembio's common stock, with a value at closing of $1,683,000, of which 7,277 shares were held back to satisfy certain potential claims under the Stock Purchase Agreement and became issuable to the sellers on the one-year anniversary of the closing; and, a contingent $148,000 milestone payment based on the achievement of performance goals related to sales by CDM during the 12 months ended December 31, 2017. The performance goals were not achieved and the related $148,000 accrual was reversed during the fourth quarter of 2017 and recognized in Selling, general, and administrative expenses associated with the change in fair value.

As a result of the consideration paid exceeding the preliminary fair value of the net assets acquired, goodwill in the amount of $1,503,361 was recorded in connection with this acquisition, none of which will be deductible for tax purposes. In addition, the Company recorded $1,800,000 in intangible assets associated with the addition of CDM’s intellectual property, customer base and distribution channels, trade names, order backlog, industry reputation, and management talent and workforce. The Condensed Consolidated Statements of Operations for the year ended December 31, 2017 include $25,000 of transaction costs related to the CDM acquisition, which are reflected as Selling, general and administrative expenses.

The acquisition was accounted for using the purchase method of accounting. The following table summarizes the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed on the closing date of January 9, 2017:


	Amount
Property, plant and equipment	$	235,141
Goodwill		1,651,361
Deferred tax liability		(307,636	)
Contingent consideration		(148,000	)
Other intangible assets (estimated useful life):
Intellectual property (10 years)		800,000
Customer contracts / relationships (10 years)		700,000
Order backlog (3 months)		200,134
Trade name (11 years)		100,000
Total consideration	$	3,231,000

The Company calculated the fair value of the fixed assets based on the net book value of CDM as that approximates fair value. The intellectual property, customer contracts and trade names were based on discounted cash flows using management estimates. The order backlog was based on an order that CDM had at the closing that was shipped in the first quarter of 2017, and valued at an estimated net income.

CDM's net revenues and pre-tax loss for the year ended December 31, 2017 were approximately $1,465,000 and ($406,000), respectively.

SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2018

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES:

(a)

Principles of Consolidation:

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany transactions and balances are eliminated in consolidation. Certain amounts from prior years have been reclassified to conform to the 2018 presentation.

(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 persuant to milestones, useful lives of intangible and fixed assets, stock-based compensation, 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.

(c)

Fair Value of Financial Instruments:

The carrying value for cash and cash equivalents, accounts receivable, and accounts payable, approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash equivalents is $4.7 million and $2.1 million as of December 31, 2018 and 2017, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company's notes payable approximates the recorded value as the rate is based upon the current rates offered to the Company for similar financial instruments.

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.

(e)

Concentrations of Credit Risk:

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments and trade receivables. The Company places its temporary cash instruments with well-known financial institutions and, at times, may maintain balances in excess of the FDIC insurance limit. The Company monitors the credit ratings of the financial institutions to mitigate this risk. Concentration of credit risk with respect to trade receivables is principally mitigated by the Company’s ability to obtain letters of credit from certain foreign customers and its diverse customer base, both in number of customers and geographic locations.

(f)

Inventories:

Inventories, consisting of material, labor and manufacturing overhead, are stated at the lower of cost and net realizable value. Cost is determined on the first-in, first-out method. The Company’s policy is to periodically evaluate the market value of the inventory and the stage of product life cycle, and record a write-down for any inventory considered slow moving or obsolete.

(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)

License Agreements:

The Company records up-front payments related to sublicense agreements as prepaids and amortizes them over their respective economic life. As of December 31, 2018 and 2017, total prepaids were $100,000 and $100,000, respectively.

Amortization expenses for the licenses above for the years ended December 31, 2018, and 2017 were $0, and $137,500, respectively.

(i)

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. No impairment of long-lived tangible and intangible assets was recorded for the years ended December 31, 2018 and 2017.

(j)

Revenue Recognition:

In May 2014, the Financial Accounting Standards Board (“FASB”) issued converged guidance on recognizing revenue in contracts with customers, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers. The intent of the new standard is to improve financial reporting and comparability of revenue globally. The core principle of the standard is for a company to recognize revenue in a manner that depicts the transfer of goods or services to customers in an amount that reflects the consideration which the company expects to receive in exchange for those goods or services. The guidance provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization of certain contract costs, consideration of the time value of money in the transaction price, and in certain circumstances, allowing estimates of variable consideration to be recognized before contingencies are resolved. The guidance also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers.

The new revenue standards became effective for the Company on January 1, 2018 and were adopted using the modified retrospective method. The adoption of the new revenue standards as of January 1, 2018 did not change the Company’s revenue recognition as its revenues continue to be recognized when the customer takes control of its product. As the Company did not identify any material accounting changes that impacted the amount of reported revenues with respect to its product revenue, license and royalty revenue, and R&D, milestone and grant revenues, no adjustment to retained earnings was required upon adoption.

The Company adopted the standards to contracts that were not completed at the date of initial application (January 1, 2018).

Under the new revenue standards, the Company recognizes revenues when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under ASU No. 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 revenues when (or as) the Company satisfies the performance obligation.

Product Revenues

Revenues 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 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 after 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’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

Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from its historical practices.

Product revenue reserves, which are classified as a reduction in product revenues, are generally related to discounts. 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 and the specific facts and circumstances of each arrangement. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, 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 cumulative revenues 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 earnings in the period of adjustment.

Royalty Revenues

The Company receives royalty revenues on sales by its licensees of products covered under patents that it owns. The Company does not have future performance obligations under these license arrangements. The Company records these revenues based on estimates of the sales that occurred during the relevant period as a component of license and royalty revenues. The relevant period estimates of sales are based on interim data provided by licensees 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 revenues 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 and grant revenue

All such contracts are evaluated under the five-step model described above. For certain contracts that represent grants where the funder does not meet the definition of a customer, the Company recognizes revenue when earned in accordance with ASC 958. Such contracts are further described under Disaggregation of Revenue, below. Grants are invoiced and revenue is recognized as expenses are incurred as that is the depiction of the timing of the transfer of services. Performance obligations generally follow the major phases of product development processes: design feasibility & planning, product development & design optimization, design verification, design validation & process validation, and pivotal studies.

Disaggregation of Revenue

The following tables disaggregate Total Revenues for the year ended December 31, 2018:


	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	26,741,020	$	-	$	26,741,020
License and royalty revenue		948,773		-		948,773
R&D, milestone and grant revenue		2,687,210		3,032,248		5,719,458
	$	30,377,003	$	3,032,248	$	33,409,251

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985.


	Total
Africa	$	8,605,306
Asia		1,389,120
Europe & Middle East		4,726,691
Latin America		11,722,224
United States		6,965,910
	$	33,409,251

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, 2017, the Company reported $50,000 in deferred revenue of which $50,000 was earned and recognized as R&D, milestone and grant revenue during the year ended December 31, 2018. At December 31, 2018, the Company reported $422,905 in deferred revenue which is expected to be recognized during the first quarter of 2019.

In April 2017, the Company entered into a $1.0 million agreement with FIND to develop a simple, point-of-care fever panel assay that can identify multiple life-threatening acute febrile illnesses common in the Asia Pacific region. The Company earned $0.1 million and $0.9 million for the year ended December 31, 2018, and from inception through December 31, 2018, respectively as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations.

In August 2016, the Company was awarded a grant of $5.9 million from BARDA, which is part of the U.S. Department of Health And Human Resources to develop a rapid Zika virus assay. The Company earned $2.6 million and $5.3 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations.

In September 2016, the Company was awarded a $0.7 million contract from the USDA to develop a Bovid TB assay. The Company earned $0.2 million and $0.5 million for the year ended December 31, 2018 and from inception through December 31, 2018, respectively, as R&D, milestone and grant revenue in the Company’s Consolidated Statements of Operations.

(k)

Research and Development:

Research and development (R&D) costs are expensed as 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 fair value of restricted stock and restricted stock unit awards are their fair value on the date of grant. Stock-based compensation expense for stock options is calculated using the Black-Scholes valuation model based on awards ultimately expected to vest together with the fair value of restricted stock and restricted stock unit awards, are, reduced for actual forfeitures, and, expensed on a straight-line basis over the requisite service period of the grant. During 2017, the Company adopted ASU 2016-09, "Improvements to Employee Share-Based Payment Accounting".

(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)

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 including outstanding restricted stock that by its terms is includible in the calculation. Diluted loss per share for the years ended December 31, 2018, and 2017 reflects the potential dilution from the exercise or conversion of other securities into common stock, if dilutive.

There were 711,968, and 810,670 options outstanding as of December 31, 2018 and 2017, respectively, which were not included in the calculation of diluted income per share for the years ended because their effect would have been anti-dilutive.

(o)

Goodwill and Intangible Assets:

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 of opTricon in November 2018 and CDM in January 2017. 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.

For the year ended December 31, 2018 and 2017, there was no impairment of goodwill and other intangible assets.

Following is a table that reflects changes in Goodwill:


Beginning balance 1/1/18	$	1,666,610

Acquisition of opTricon		3,337,000

Changes in foreign currency exchange rate		(20,483	)

Balance at December 31, 2018	$	4,983,127

Intangible assets consist of the following at:

	Weighted Average Remaining Life		December 31, 2018						December 31, 2017
	Weighted Average Remaining Life		Cost		Accumulated Amortization		Net Book Value		Cost		Accumulated Amortization		Net Book Value
Intellectual property		10	$	1,089,688	$	173,633	$	916,055	$	886,872	$	88,687	$	798,185
Developed technology		7		1,910,315		-		1,910,315		-		-		-
Customer contracts/relationships		8		1,121,600		151,929		969,671		776,013		77,601		698,412
Order backlog		-		217,187		217,187		-		221,867		221,867		-
Trade names		9		108,521		19,731		88,790		110,859		10,079		100,780
			$	4,447,311	$	562,480	$	3,884,831	$	1,995,611	$	398,234	$	1,597,377

Amortization expense for the year ended December 31, 2018 and 2017 was $233,734 and $398,234, respectively, and is recorded within Selling, General and Administrative expenses. Amortization expense, subject to changes in currency exchange rates, is expected to be $496,512 per year from 2019 through 2023, and total $1,402,271 for all of the years thereafter.

(p)

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.

(q)

Acquisition Costs:

Acquisition costs include period expenses, primarily professional services, related to acquisition activities.

(r)

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 generally reported in Other comprehensive income. Foreign transaction gains are immaterial.

(s)

Recent Accounting Pronouncements Affecting the Company:

The Company has completed its evaluation of the new standard and assessed the impact of adoption on its consolidated financial statements. The Company reviewed significant open contracts with customers for each revenue stream, and based on its evaluation, revenue recognition under the new standard did not have a material impact on the Company’s consolidated financial statements because: i) product sales revenue is recognized when control of the goods is transferred to the customer (i.e., the date of shipment, which is consistent under ASC 605), and ii) R&D and grant revenue historically did not constitute exchange transactions and therefore the new standard did not apply to such revenue upon adoption. The Company also assessed its control framework as a result of adopting the new standard and noted minimal, insignificant changes to its systems and other controls processes.

The new standard permitted two adoption methods under ASU 2014-09. The guidance could be adopted through either retrospective application to all periods presented in the consolidated financial statements (full retrospective) or through a cumulative effect adjustment to retained earnings at the effective date (modified retrospective). The Company adopted the new standard effective January 1, 2018 using the modified retrospective transition method. Under that method, the Company applied the rules to all contracts existing as of January 1, 2018. The cumulative effect was not material.

In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740) Balance Sheet Classification of Deferred Assets. This ASU is intended to simplify the presentation of deferred taxes on the balance sheet and will require an entity to present all deferred tax assets and deferred tax liabilities as non-current on the balance sheet. Under the current guidance, entities are required to separately present deferred taxes as current or non-current. Netting deferred tax assets and deferred tax liabilities by tax jurisdiction will still be required under the new guidance. This guidance became effective for Chembio beginning in 2018. This new accounting standard update did not have a material impact on the Company's consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 requires the entity to recognize the assets and liabilities for the rights and obligations created by leased assets. Leases will be classified as either finance or operating, with classification affecting expense recognition in the income statement. In July 2018 the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, and ASU 2018-11, Leases (Topic 842) Targeted Improvements, which provide supplemental adoption guidance and clarification to ASU 2016-02, and must be adopted concurrently with the adoption of ASU 2016-02, cumulatively referred to as “Topic 842”. Topic 842 is effective for the company in the first quarter of 2019, with early adoption permitted, and is to be applied using either a modified retrospective approach, or an optional transition method which allows an entity to apply the new standard at the adoption date with a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.

The Company will adopt Topic 842 on January 1, 2019 under the optional transition method and elect the short-term lease exception and available practical expedients. Under the transition method, the Company will not adjust its comparative period financial information or make the new required lease disclosures for periods before the effective date. Upon adoption, the Company expects the consolidated balance sheet to include a right of use asset and liability related to substantially all of the Company’s lease arrangements. While the Company continues to evaluate the effects of adopting the provisions of Topic 842, including the impact that this new guidance will have on its processes and controls, the Company expects most existing operating lease commitments will be recognized as operating lease liabilities and right-of-use assets upon adoption. The adoption is not expected to be material to the consolidated financial statements, and based on the Company’s ongoing assessment, is expected to increase total assets and total liabilities by no more than approximately $1.5 million, on a discounted basis.

Pleasesee Note 15 – Subsequent Events, regarding the Company’s entering into a commercial real estate lease for a new corporate headquarters and a sublease for one of its current facilities on February 5, 2019. The Company is currently analyzing the impact of Topic 842 on these transactions and expects to report on that during the first quarter of 2019. Based on the term and rental cost, the Company expects the application of Topic 842 to these transactions to have a material impact on the Company’s total assets and total liabilities, and no impact on the Company’s results of operations or cash flows.

In March 2016, the FASB issued authoritative guidance under ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 provides for simplification of several aspects of the accounting for share-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The Company adopted ASU 2016-09 on January 1, 2017. As the Company has a full valuation allowance against its U.S. net deferred tax assets, the adoption of this standard for recognition of the tax effect of deductions for employee share awards in excess of compensation costs (“windfall”) did not have a material impact on its consolidated financial statements and related disclosures. See Note 8 – Income Taxes, for additional information. Should the full valuation allowance be reversed in future periods, the adoption of this new guidance could introduce more volatility in the calculation of the Company’s effective tax rate, depending on the Company’s share price at exercise or vesting of share-based awards as compared to grant date. The other provisions of ASU 2016-09 did not have a material impact on the Company's consolidated financial statements and related disclosures.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, which provides guidance related to cash flows presentation. The Company adopted ASU 2016-15 in the first quarter of 2018. The guidance in ASU 2016-15 is generally consistent with the Company’s current cash flow classifications, and did not have a material impact on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, which requires an entity to no longer perform a hypothetical purchase price allocation to measure goodwill impairment. Instead, impairment will be measured using the difference between the carrying amount and the fair value of the reporting unit. This update will be effective for annual and interim periods in fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company adopted ASU 2017-04 in the fourth quarter of 2017. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements and related disclosures.

In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, to provide clarity to which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The Company adopted ASU 2017-09 in the first quarter of 2018. Adoption did not have a material effect on the Company’s consolidated financial statements.

In July 2018, 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 to clarify the accounting guidance related to contributions made or received. This guidance primarily affects not-for-profit entities, although it also applies to businesses to the extent that they make or receive contributions, including grants. ASU 2018-08 clarifies and improves the scope and accounting guidance for both contributions received and made in order to assist entities in evaluating if those transactions should be accounted for as contributions under the scope of Topic 958, or as an exchange transaction subject to other guidance. Public entities are required to apply the amendments on contributions received and contributions made to annual periods beginning after June 15, 2018, and December 15, 2018, respectively, each including interim periods within those annual periods. Early adoption is permitted, and the Company adopted ASU 2018-08 effective as of January 1, 2018. The impact of adoption was immaterial.

INVENTORIES

12 Months Ended

Dec. 31, 2018

INVENTORIES [Abstract]

INVENTORIES

NOTE 4 — INVENTORIES:

Inventories consist of the following at:

	December 31, 2018		December 31, 2017
Raw Materials	$	2,803,677	$	1,767,684
Work in Process		263,043		286,413
Finished Goods		4,784,502		2,369,521
	$	7,851,222	$	4,423,618

FIXED ASSETS

12 Months Ended

Dec. 31, 2018

FIXED ASSETS [Abstract]

FIXED ASSETS

NOTE 5 — FIXED ASSETS:

Fixed assets consist of the following at:

	December 31, 2018			December 31, 2017
Machinery and Equipment	$	6,070,137		$	4,582,759
Furniture and Fixtures		35,287			449,548
Computer Equipment		435,348			422,946
Leasehold Improvements		2,334,512			2,258,779
Enterprise Business Systems		462,420			-
Less: Accumulated Depreciation and Amortization		(6,463,784	)		(5,804,800	)
	$	2,873,920		$	1,909,232

There were no capital leases at the end of December 31, 2018. Fixed assets at December 31, 2018 also include $1,866,126 in equipment that is undergoing validation and as such is not yet being depreciated. Depreciation expense for the 2018 and 2017 years totaled $634,261 and $727,563, respectively.

As of December 31, 2018 and 2017, the Company had paid deposits on various pieces of equipment classified within Deposits and Other Assets aggregating $428,859 and $257,455, respectively.

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

12 Months Ended

Dec. 31, 2018

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

NOTE 6 — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES:

Accounts payable and accrued liabilities consist of the following at:

	December 31, 2018		December 31, 2017
Accounts Payable - suppliers	$	3,622,765	$	1,494,759
Accrued Commissions		588,131		126,827
Accrued Royalties / license fees		279,213		429,297
Accrued Payroll		48,867		187,305
Accrued Vacation		264,789		309,767
Accrued Bonuses		494,318		282,500
Accrued Expenses - Other		590,598		215,848
	$	5,888,681	$	3,046,303

DEFERRED RESEARCH AND DEVELOPMENT REVENUE	12 Months Ended
DEFERRED RESEARCH AND DEVELOPMENT REVENUE	Dec. 31, 2018
DEFERRED RESEARCH AND DEVELOPMENT REVENUE [Abstract]
DEFERRED RESEARCH AND DEVELOPMENT REVENUE	NOTE 7 — DEFERRED RESEARCH AND DEVELOPMENT REVENUE: The Company recognizes income from R&D milestones when those milestones are reached and non-milestone contracts and grants when earned. These projects are invoiced after expenses are incurred. Any projects or grants funded in advance are deferred until earned. As of December 31, 2018 and 2017, there were $422,905 and $50,000 unearned advanced revenues, respectively.

INCOME TAXES

12 Months Ended

Dec. 31, 2018

INCOME TAXES [Abstract]

INCOME TAXES

NOTE 8 — INCOME TAXES:

The (benefit from) provision for income taxes for the years ended December 31, 2018 and 2017 is comprised of the following:

	2018			2017
Current
Federal	$	-		$	(97,339	)
State		10,914			9,034
Foreign		-			-
Total current (benefit) provision		10,914			(88,305	)

Deferred
Federal		-			-
State		-			-
Foreign		(78,435	)		-
Total deferred (benefit) provision		(78,435	)		-

Total (benefit) provision	$	(67,521	)	$	(88,305	)

On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 34% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017. The Staff of the Securities and Exchange Commission issued Staff Accounting Bulletin No. 118 ("SAB 118") to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. As a result of the Tax Act, the Company remeasured its U.S. Federal deferred tax assets and liabilities at the rate they are expected to reverse in the future. The Company recorded a cumulative charge of $3,906,774 ($0 in 2018 and $3,906,774 in 2017), which was fully offset by an equivalent adjustment to the deferred tax valuation allowance. The Company recorded a cumulative benefit of $97,339 ($0 in 2018 and $97,339 in 2017) related to a credit for alternative minimum taxes (AMT) paid in prior years. During 2018, the Company finalized its computation of the impact of the Tax Act with no change to the provisional amount.

In January 2018, the FASB released guidance on the accounting for tax on the global intangible low-taxed income ("GILTI") provisions of the Tax Act. The GILTI provisions impose a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations. The guidance allows companies to make an accounting policy election to either (1) account for GILTI as a component of tax expense in the period in which they are subject to the rules (the period cost method), or (ii) account for GILTI in the Company's measurement of deferred taxes (the deferred method). After completing the analysis of the GILTI provisions, the Company elected to account for GILTI using the period cost method.

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 2019 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 2024 through 2026.

After applying the above limitations, at December 31, 2018, the Company has post-change net operating loss carry-forwards of approximately $27,303,044 which expire between 2019 and 2037 and $5,432,085 which do not expire. In addition the Company has research and development tax credit carryforwards of approximately $1,696,870 for the year ended December 31, 2018, which expire between 2019 and 2036.

The Company has state net operating loss carryforwards of approximately $1,784,554 which expire between 2025 and 2037. The Company has foreign net operating loss carryforwards of approximately $586,206 which do not expire.

	2018			2017

Inventory reserves	$	204,206		$	244,158
Accrued expenses		175,168			102,332
Net operating loss carry-forwards		7,122,576			5,800,144
Research and development credit		1,696,870			1,918,137
Stock-based compensation		215,797			167,522
Depreciation		139,362			91,258
Total deferred tax assets		9,553,979			8,323,551

Intangibles		(968,849	)		(341,042	)
Total deferred tax liabilities		(968,849	)		(341,042	)

Net deferred tax assets before valuation allowance		8,585,130			7,982,509
Less valuation allowances		(9,477,438	)		(8,323,551	)
Net noncurrent deferred tax liabilities	$	(892,308	)	$	(341,042	)

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

	Year Ending December 31,
	2018			2017
United States operations	$	(7,137,428	)	$	(6,054,002	)
International operations		(795,742	)		(406,063	)
(Loss) before taxes	$	(7,933,170	)	$	(6,460,065	)

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

	Year Ending December 31,
	2018			2017
Federal income tax at statutory rates		21.00	%		34.00	%
State income taxes, net of federal benefit		(.10	)%		(0.09	)%
Nondeductible expenses		(1.58	)%		(1.04	)%
Foreign rate differential		.36	%		(2.14	)%
Change in valuation allowance		(18.44	)%		(99.41	)%
Impact of Tax Act on valuation allowance		-	%		60.48	%
AMT refund under Tax Act		-	%		1.51	%
Tax credits		-	%		7.07	%
Other		(.39	)%		0.99	%
Income tax benefit		.85	%		1.37	%

Interest and penalties, if any, related to income tax liabilities are included in income tax expense. As of December 31, 2018, the Company does not have a liability for uncertain tax positions.

The Company files Federal and state income tax returns, opTricon files in Germany and CDM files in Malaysia and has been on tax holiday which expired on December 31, 2018. With few exceptions, tax years for fiscal 2015 through 2018 are open and potentially subject to examination by federal, state and foreign taxing authorities.

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2018

STOCKHOLDERS' EQUITY [Abstract]

STOCKHOLDERS' EQUITY

NOTE 9 — STOCKHOLDERS’ EQUITY:

(a)

Common Stock

In February 2018, the Company closed on an underwritten registered public offering of 1,783,760 shares of its common stock at $6.75 per share. The net proceeds of the offering, after deducting the underwriter’s discounts and other offering expenses payable by the Company, was approximately $10.9 million.

In November 2018, the Company closed on an underwritten public offering of 2,726,000 shares of its common stock, including the underwriter’s exercise of its overallotment of 355,565 shares, at $6.75 per share. The net proceeds of the offering, after deducting the underwriter’s discounts and other offering expenses payable by the Company, was approximately $16.5 million.

During 2018, options to purchase 144,947 shares of the Company’s common stock were exercised for 71,290 shares of common stock at exercise prices ranging from $3.48 to $5.64 by surrendering options and shares of common stock already owned.

During 2017, options to purchase 56,969 shares of the Company’s common stock were exercised for 22,487 shares of common stock at exercise prices ranging from $3.48 to $4.45 by surrendering options and shares of common stock already owned.

(b)

Preferred Stock

The Company 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 and the filing of a Certificate of Designation with the state of Nevada.

(c)

Options, Restricted Stock, and Restricted Stock Units

The Board of Directors or its Compensation Committee may issue options, restricted stock, and restricted stock units pursuant to employee stock incentive plans that have been approved by the Company's stockholders.

(d)

Warrants

As of December 31, 2018 and 2017, the Company had no warrants outstanding to purchase shares of common stock.

RIGHTS AGREEMENT	12 Months Ended
RIGHTS AGREEMENT	Dec. 31, 2018
RIGHTS AGREEMENT [Abstract]
RIGHTS AGREEMENT	NOTE 10 — RIGHTS AGREEMENT: In March 2016, the Company entered into a Rights Agreement (the "Rights Agreement") with Action Stock Transfer Corp., as Rights Agent. The Rights Agreement expired on March 7, 2019. Pursuant to the Rights Agreement, the Company declared a dividend distribution of one preferred share purchase right (a "Right") for each outstanding share of common stock as of March 8, 2016. Rights Initially Not Exercisable. The Rights were not exercisable until a Distribution Date (as defined below). Until a Right was exercised, the holder thereof, as such, would have no rights as a shareholder of the Company, including, without limitation, the right to vote or to receive dividends. Separation and Distribution of Rights. The Rights were evidenced by the certificates for common stock, and were not to be evidenced by separate rights certificates until the close of business on the tenth business day (the “Distribution Date”) following either (i) a public announcement that a person or group acquired beneficial ownership of 20% or more of the outstanding shares of common stock or (ii) a tender or exchange offer by any person or group is first published, sent or given within the meaning of Rule 14d-3(a) under the Securities Exchange Act of 1934, the consummation of which would result in the person or group having beneficial ownership of 20% or more of the outstanding shares of common stock.

STOCK INCENTIVE PLANS

12 Months Ended

Dec. 31, 2018

STOCK INCENTIVE PLANS [Abstract]

STOCK INCENTIVE PLANS

NOTE 11 — STOCK INCENTIVE PLANS:

Effective June 3, 2008, the Company’s stockholders voted to approve the 2008 Stock Incentive Plan (“SIP”), with 625,000 shares of common stock available to be issued. At the Annual Stockholder Meeting on September 22, 2011 the Company’s stockholders voted to approve an increase to the shares of common stock issuable under the SIP by 125,000 to 750,000. Under the terms of the SIP, which expired during 2018, the Board of Directors or its Compensation Committee had the discretion to select the persons to whom awards were to be granted. Awards could be stock options, restricted stock and/or restricted stock units ("Equity Award Units"). The awards became vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through December 31, 2018, there were 508,889 options exercised, and at December 31, 2018, 99,132 options were outstanding and no Equity Award Units were available to be issued under the SIP.

Effective June 19, 2014, the Company’s stockholders voted to approve the 2014 Stock Incentive Plan (“SIP14”), with 800,000 shares of common stock available to be issued. Under the terms of the SIP14, 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 become vested at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through December 31, 2018, there were 85,407 options exercised, and at December 31, 2018, 405,968 options were outstanding and 21,061 Equity Award Units were still available to be issued under the SIP14. During 2018, 266,839 shares of restricted stock and 20,725 restricted stock units were awarded under SIP14.

The Company's results for the years ended December 31, 2018 and 2017 include stock-based compensation expense totaling $632,805 and $384,897, respectively. Such amounts have been included in the Consolidated Statements of Operations within cost of goods sold ($25,615 and $47,000, respectively), research and development ($78,831 and $89,400, respectively) and selling, general and administrative expenses ($528,360 and $248,497, respectively).

Stock option compensation expense in the years ended December 31, 2018 and 2017 represents the estimated fair value of options outstanding which is being amortized on a straight-line basis over the requisite vesting period of the entire award.

The weighted average estimated fair value of stock options granted in the years ended December 31, 2018 and 2017 were $3.76 and $2.77 per share, respectively. The fair value of options at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon historical volatility of the Company’s stock and other contributing factors. The expected term is based on the Company’s historical experience with similar type options.

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

	December 31, 2018			December 31, 2017
Expected term (in years)		4.96			5.48
Expected volatility		39.91	%		43.31	%
Expected dividend yield		n/a			n/a
Risk-free interest rate		2.70	%		1.78	%

The Company granted 93,750 new options during the year ended December 31, 2018.

The following table provides stock option activity for the years ended December 31, 2018 and 2017:

	Number of Shares		Weighted Average Exercise Price per Share		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at December 31, 2016		600,549		4.55	3.43 years	$	1,463,052

Granted		267,875		6.40
Exercised		56,969		4.19			100,018
Forfeited/expired/cancelled		785		5.56
Outstanding at December 31, 2017		810,670		5.18	3.69 years	$	2,477,853

Exercisable at December 31, 2017		371,295		4.44	2.62 years	$	1,409,440

Outstanding at December 31, 2017		810,670	$	5.18	3.69 years	$	2,477,853

Granted		93,750	$	9.80			352,220
Exercised		144,947	$	4.83			523,327
Forfeited/expired/cancelled		47,505	$	8.82			154,583
Outstanding at December 31, 2018		711,968	$	5.62	3.33 years	$	687,364

Exercisable at December 31, 2018		396,799	$	4.70	2.66 years	$	568,956

The following table summarizes information about stock options outstanding at December 31, 2018:

	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		-		-	$	-	$	-		-	$	-	$	-
2.8 to 4.59999		304,343		1.90		3.45		672,896		254,343		3.46		560,711
4.6 to 6.39999		152,875		3.43		5.85		14,468		58,020		5.80		8,245
6.4 to 8.19999		207,875		5.05		7.31		-		75,041		7.21		-
8.2 to 12		46,875		4.60		11.45		-		9,375		11.45		-
Total		711,968		3.33	$	5.62	$	687,364		396,779	$	4.70	$	568,956

As of December 31, 2018, there was $710,376 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 2.45 years. The total fair value of shares vested during the year ended December 31, 2018, was $553,000.

The following table summarizes information about restricted stock and restricted stock units outstanding as of December 31, 2018:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Outstanding at December 31, 2017		-	$	-

Granted		287,564		9.65
Exercised		-		-
Forfeited/expired/cancelled		-		-
Outstanding at December 31, 2018		287,564		9.65

Exercisable at December 31, 2018		-	$	-

As of December 31, 2018, there was $1,688,746 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 2.5 years. Stock based compensation cost related to restricted stock and restricted stock units recognized during the years ended December 31, 2018 and 2017 was $281,249 and $0, respectively.

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

12 Months Ended

Dec. 31, 2018

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY

NOTE 12 — GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY:

The Company produces only one group of similar products known collectively as “rapid medical tests,” and it operates in a single business segment. Net product sales by geographic area are as follows:

	For the years ended
	December 31, 2018		December 31, 2017
Africa	$	8,605,306	$	3,568,455
Asia		1,389,120		1,626,750
Europe & Middle East		2,172,031		1,763,274
Latin America		11,722,224		8,476,003
United States		2,852,339		3,887,820
	$	26,741,020	$	19,322,302

Long-lived assets by geographic area are as follows:

	2018		2017
Asia	$	466,185	$	472,774
Europe & Middle East		123,752		-
United States		2,283,983		1,436,458
	$	2,873,920	$	1,909,232

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS

12 Months Ended

Dec. 31, 2018

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract]

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS

NOTE 13 — COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS:

Employment Contracts:

The Company has multi-year contracts with two key employees. The contracts call for salaries presently aggregating $770,000 per year, and they expire in March 2019 and March 2020. The following table is a schedule of future minimum salary commitments:

2019		$	485,493
2020			85,000

Pension 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 $94,544 and $91,150 for the years ended December 31, 2018 and 2017, respectively.

Obligations Under Operating Leases:

The Company leases industrial space used for office, R&D and manufacturing facilities, currently with a monthly rent of $30,140. The current lease expires on April 30, 2019. The lease provides for annual increases of 2.5% percent each year starting May 1, 2016. In February of 2014, the Company entered into a lease for office and warehouse space, effective March 1, 2014, a short distance from its current facility currently with a monthly rent of $16,709. The space is used primarily for warehousing and provides for additional office space. The lease expires on April 30, 2020. The lease provides for annual increases of 3.0% percent each year starting March 1, 2016. The Company also leases office, warehouse, and manufacturing space in a single building in Kuala Lumpur, Malaysia persuant to two separate leases that each expire on April 30, 2020 and have an additional three year renewal option with combined monthly rent of approximately $5,400. The Company also leases space in Germany for offices, manufacturing, and center of excellence for optical technology. The lease will automatically renew annually on May 31. The monthly cost is estimated at $13,445 with yearly increases of 2%.

The following is a schedule of future minimum rental commitments for the years ending December 31,

2019	$	384,308
2020		88,576
2021		-
	$	472,884

Rent expense was $653,155 and $586,730 for the years ended December 31, 2018 and 2017, respectively.

Economic Dependency:

Customers are considered major customers when net sales exceed 10% of the Company's total net sales for period or outstanding trade receivables exceed 10% of accounts receivable. The Company had the following major customers for the respective periods:

	For the years ended										Accounts Receivable
	December 31, 2018					December 31, 2017					December 31, 2018		December 31, 2017
	Sales		% of Sales			Sales		% of Sales
Customer 1	$	11,171,174		42	%	$	8,065,217		42	%	$	3,499,340	$	-
Customer 2		4,346,640		16	%		-		-	%		1,033,824		-

The following table delineates purchases the Company had with vendors in excess of 10% of total purchases for the periods indicated:

For the years ended

Accounts Payable

December 31, 2018

December 31, 2017

December 31, 2018

December 31, 2017

Purchases

% of Purc.

Purchases

% of Purc.

Vendor 1

Vendor 2

746,868

Vendor 3

849,966

164,312

Vendor 4

1,646,614

884,698

In the tables above, an asterisk (*) indicates that purchases from the vendor 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:

From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. The outcomes of such actions, either individually or in the aggregate, are not expected to have a material adverse effect on the Company’s future financial position or results of operations.

NOTE PAYABLE	12 Months Ended
NOTE PAYABLE	Dec. 31, 2018
NOTE PAYABLE [Abstract]
NOTE PAYABLE	NOTE 14 — NOTE PAYABLE: In September 2017, the Company entered into an agreement with an equipment vendor to purchase automated assembly equipment for approximately $660,000. The terms call for prepayments of 30% down, 60% at time of factory acceptance testing and 10% after delivery. The vendor agreed to lend the Company 15%, 40%, and 10% of each originally scheduled payment, respectively. The Company will pay interest at an annual rate of 12% until delivery. Beginning in September 2018, the Company began making monthly payments of principal and interest of approximately $20,150, at an annual rate of 12% over a twenty-four month period.

SUBSEQUENT EVENTS	12 Months Ended
SUBSEQUENT EVENTS	Dec. 31, 2018
SUBSEQUENT EVENTS [Abstract]
SUBSEQUENT EVENTS	NOTE 15 — SUBSEQUENT EVENTS: On February 5, 2019, the Company entered into a commercial real estate lease for a new corporate headquarters comprised of 70,000 square feet of office, research and development, and warehouse space in Hauppauge, New York. The lease has an initial term of eleven years that can be extended, at the Company’s option, for two additional terms of five years each. Rent under the lease, which is payable in monthly installments, totals approximately $900,000 for the initial year and then increases by approximately three percent each succeeding year. Upon lease inception, the Company provided a security deposit and paid four months base rent that together totaled approximately $450,000. The base rent which will be deducted against the rent due following a nine-month free rent period. On February 5, 2019, the Company also entered into an agreement of sublease with an affiliate of the Hauppauge, NY facility landlord to sublet the Company’s warehouse space and supplemental administrative office facility in Holbrook, New York. The sublease has a term that will (a) commence on the later of March 18, 2019 and the date the Company vacates the premises and (b) terminate on April 29, 2020, which is immediately prior to the termination of the Company’s lease for the facility. The sublessee will pay the Company 50% of the Company’s rent and additional rent payments, which will total approximately $100,000 per year during the term of the sublease.

SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2018

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

Principles of Consolidation

(a)

Principles of Consolidation:

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.

Concentrations of Credit Risk

(e)

Concentrations of Credit Risk:

Inventories

(f)

Inventories:

Fixed Assets

(g)

Fixed Assets:

License Agreements

(h)

License Agreements:

Amortization expenses for the licenses above for the years ended December 31, 2018, and 2017 were $0, and $137,500, respectively.

Valuation of Long-Lived Assets and Intangible Assets

(i)

Valuation of Long-Lived Assets and Intangible Assets:

Revenue Recognition

(j)

Revenue Recognition:

The Company adopted the standards to contracts that were not completed at the date of initial application (January 1, 2018).

Product Revenues

Reserves for Discounts and Allowances

Royalty Revenues

R&D and grant revenue

Disaggregation of Revenue

The following tables disaggregate Total Revenues for the year ended December 31, 2018:


	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	26,741,020	$	-	$	26,741,020
License and royalty revenue		948,773		-		948,773
R&D, milestone and grant revenue		2,687,210		3,032,248		5,719,458
	$	30,377,003	$	3,032,248	$	33,409,251

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985.


	Total
Africa	$	8,605,306
Asia		1,389,120
Europe & Middle East		4,726,691
Latin America		11,722,224
United States		6,965,910
	$	33,409,251

Contract Liabilities

Research and Development

(k)

Research and Development:

Stock-Based Compensation

(l)

Stock-Based Compensation:

Income Taxes

(m)

Income Taxes:

Loss Per Share

(n)

Loss Per Share:

Goodwill and Intangible Assets

(o)

Goodwill and Intangible Assets:

For the year ended December 31, 2018 and 2017, there was no impairment of goodwill and other intangible assets.

Following is a table that reflects changes in Goodwill:


Beginning balance 1/1/18	$	1,666,610

Acquisition of opTricon		3,337,000

Changes in foreign currency exchange rate		(20,483	)

Balance at December 31, 2018	$	4,983,127

Intangible assets consist of the following at:

	Weighted Average Remaining Life		December 31, 2018						December 31, 2017
	Weighted Average Remaining Life		Cost		Accumulated Amortization		Net Book Value		Cost		Accumulated Amortization		Net Book Value
Intellectual property		10	$	1,089,688	$	173,633	$	916,055	$	886,872	$	88,687	$	798,185
Developed technology		7		1,910,315		-		1,910,315		-		-		-
Customer contracts/relationships		8		1,121,600		151,929		969,671		776,013		77,601		698,412
Order backlog		-		217,187		217,187		-		221,867		221,867		-
Trade names		9		108,521		19,731		88,790		110,859		10,079		100,780
			$	4,447,311	$	562,480	$	3,884,831	$	1,995,611	$	398,234	$	1,597,377

Allowance for Doubtful Accounts

(p)

Allowance for Doubtful Accounts:

Acquisition Costs

(q)

Acquisition Costs:

Acquisition costs include period expenses, primarily professional services, related to acquisition activities.

Foreign Currency Translation

(r)

Foreign Currency Translation:

Recent Accounting Pronouncements Affecting the Company

(s)

Recent Accounting Pronouncements Affecting the Company:

ACQUISITIONS (Tables)

12 Months Ended

Dec. 31, 2018

Business Acquisition [Line Items]

Unaudited Pro forma Operating Results

	Proforma
	December 31, 2018
Total revenues	$	35,442,806

Net loss		(8,394,074	)

Net loss per common share	$	(0.58	)

Diluted net loss per common share	$	(0.58	)

op Tricon [Member]

Business Acquisition [Line Items]

Fair Values of Assets Acquired and Liabilities Assumed


	Amount
Net current assets	$	404,204
Property, plant and equipment		125,000
Goodwill		3,337,000
Deferred tax liability		(635,000	)
Other intangible assets (estimated useful life):
Developed technology (7 years)		1,900,000
Customer contracts / relationships (10 years)		360,000
Total consideration	$	5,491,204

RVR Diagnostics Sdn Bhd [Member]

Business Acquisition [Line Items]

Fair Values of Assets Acquired and Liabilities Assumed


	Amount
Property, plant and equipment	$	235,141
Goodwill		1,651,361
Deferred tax liability		(307,636	)
Contingent consideration		(148,000	)
Other intangible assets (estimated useful life):
Intellectual property (10 years)		800,000
Customer contracts / relationships (10 years)		700,000
Order backlog (3 months)		200,134
Trade name (11 years)		100,000
Total consideration	$	3,231,000

SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2018

SIGNIFICANT ACCOUNTING POLICIES [Abstract]

Disaggregation of Revenue

The following tables disaggregate Total Revenues for the year ended December 31, 2018:


	Exchange Transactions		Non-Exchange Transactions		Total
Net product sales	$	26,741,020	$	-	$	26,741,020
License and royalty revenue		948,773		-		948,773
R&D, milestone and grant revenue		2,687,210		3,032,248		5,719,458
	$	30,377,003	$	3,032,248	$	33,409,251

Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASC 985.


	Total
Africa	$	8,605,306
Asia		1,389,120
Europe & Middle East		4,726,691
Latin America		11,722,224
United States		6,965,910
	$	33,409,251

Changes in Goodwill

Following is a table that reflects changes in Goodwill:


Beginning balance 1/1/18	$	1,666,610

Acquisition of opTricon		3,337,000

Changes in foreign currency exchange rate		(20,483	)

Balance at December 31, 2018	$	4,983,127

Intangible Assets

Intangible assets consist of the following at:

	Weighted Average Remaining Life		December 31, 2018						December 31, 2017
	Weighted Average Remaining Life		Cost		Accumulated Amortization		Net Book Value		Cost		Accumulated Amortization		Net Book Value
Intellectual property		10	$	1,089,688	$	173,633	$	916,055	$	886,872	$	88,687	$	798,185
Developed technology		7		1,910,315		-		1,910,315		-		-		-
Customer contracts/relationships		8		1,121,600		151,929		969,671		776,013		77,601		698,412
Order backlog		-		217,187		217,187		-		221,867		221,867		-
Trade names		9		108,521		19,731		88,790		110,859		10,079		100,780
			$	4,447,311	$	562,480	$	3,884,831	$	1,995,611	$	398,234	$	1,597,377

INVENTORIES (Tables)

12 Months Ended

Dec. 31, 2018

INVENTORIES [Abstract]

Inventories

Inventories consist of the following at:

	December 31, 2018		December 31, 2017
Raw Materials	$	2,803,677	$	1,767,684
Work in Process		263,043		286,413
Finished Goods		4,784,502		2,369,521
	$	7,851,222	$	4,423,618

FIXED ASSETS (Tables)

12 Months Ended

Dec. 31, 2018

FIXED ASSETS [Abstract]

Fixed Assets

Fixed assets consist of the following at:

	December 31, 2018			December 31, 2017
Machinery and Equipment	$	6,070,137		$	4,582,759
Furniture and Fixtures		35,287			449,548
Computer Equipment		435,348			422,946
Leasehold Improvements		2,334,512			2,258,779
Enterprise Business Systems		462,420			-
Less: Accumulated Depreciation and Amortization		(6,463,784	)		(5,804,800	)
	$	2,873,920		$	1,909,232

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2018

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]

Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities consist of the following at:

	December 31, 2018		December 31, 2017
Accounts Payable - suppliers	$	3,622,765	$	1,494,759
Accrued Commissions		588,131		126,827
Accrued Royalties / license fees		279,213		429,297
Accrued Payroll		48,867		187,305
Accrued Vacation		264,789		309,767
Accrued Bonuses		494,318		282,500
Accrued Expenses - Other		590,598		215,848
	$	5,888,681	$	3,046,303

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2018

INCOME TAXES [Abstract]

(Benefit) Provision for Income Taxes

The (benefit from) provision for income taxes for the years ended December 31, 2018 and 2017 is comprised of the following:

	2018			2017
Current
Federal	$	-		$	(97,339	)
State		10,914			9,034
Foreign		-			-
Total current (benefit) provision		10,914			(88,305	)

Deferred
Federal		-			-
State		-			-
Foreign		(78,435	)		-
Total deferred (benefit) provision		(78,435	)		-

Total (benefit) provision	$	(67,521	)	$	(88,305	)

Deferred Tax Assets and Liabilities

	2018			2017

Inventory reserves	$	204,206		$	244,158
Accrued expenses		175,168			102,332
Net operating loss carry-forwards		7,122,576			5,800,144
Research and development credit		1,696,870			1,918,137
Stock-based compensation		215,797			167,522
Depreciation		139,362			91,258
Total deferred tax assets		9,553,979			8,323,551

Intangibles		(968,849	)		(341,042	)
Total deferred tax liabilities		(968,849	)		(341,042	)

Net deferred tax assets before valuation allowance		8,585,130			7,982,509
Less valuation allowances		(9,477,438	)		(8,323,551	)
Net noncurrent deferred tax liabilities	$	(892,308	)	$	(341,042	)

Components of (Loss) Before Income Taxes

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

	Year Ending December 31,
	2018			2017
United States operations	$	(7,137,428	)	$	(6,054,002	)
International operations		(795,742	)		(406,063	)
(Loss) before taxes	$	(7,933,170	)	$	(6,460,065	)

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,
	2018			2017
Federal income tax at statutory rates		21.00	%		34.00	%
State income taxes, net of federal benefit		(.10	)%		(0.09	)%
Nondeductible expenses		(1.58	)%		(1.04	)%
Foreign rate differential		.36	%		(2.14	)%
Change in valuation allowance		(18.44	)%		(99.41	)%
Impact of Tax Act on valuation allowance		-	%		60.48	%
AMT refund under Tax Act		-	%		1.51	%
Tax credits		-	%		7.07	%
Other		(.39	)%		0.99	%
Income tax benefit		.85	%		1.37	%

STOCK INCENTIVE PLANS (Tables)

12 Months Ended

Dec. 31, 2018

STOCK 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, 2018			December 31, 2017
Expected term (in years)		4.96			5.48
Expected volatility		39.91	%		43.31	%
Expected dividend yield		n/a			n/a
Risk-free interest rate		2.70	%		1.78	%

Stock Option Activity

The following table provides stock option activity for the years ended December 31, 2018 and 2017:

	Number of Shares		Weighted Average Exercise Price per Share		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
Outstanding at December 31, 2016		600,549		4.55	3.43 years	$	1,463,052

Granted		267,875		6.40
Exercised		56,969		4.19			100,018
Forfeited/expired/cancelled		785		5.56
Outstanding at December 31, 2017		810,670		5.18	3.69 years	$	2,477,853

Exercisable at December 31, 2017		371,295		4.44	2.62 years	$	1,409,440

Outstanding at December 31, 2017		810,670	$	5.18	3.69 years	$	2,477,853

Granted		93,750	$	9.80			352,220
Exercised		144,947	$	4.83			523,327
Forfeited/expired/cancelled		47,505	$	8.82			154,583
Outstanding at December 31, 2018		711,968	$	5.62	3.33 years	$	687,364

Exercisable at December 31, 2018		396,799	$	4.70	2.66 years	$	568,956

Stock Options Outstanding

The following table summarizes information about stock options outstanding at December 31, 2018:

	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		-		-	$	-	$	-		-	$	-	$	-
2.8 to 4.59999		304,343		1.90		3.45		672,896		254,343		3.46		560,711
4.6 to 6.39999		152,875		3.43		5.85		14,468		58,020		5.80		8,245
6.4 to 8.19999		207,875		5.05		7.31		-		75,041		7.21		-
8.2 to 12		46,875		4.60		11.45		-		9,375		11.45		-
Total		711,968		3.33	$	5.62	$	687,364		396,779	$	4.70	$	568,956

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, 2018:

	Number of Shares & Units		Weighted Average Grant Date Fair Value
Outstanding at December 31, 2017		-	$	-

Granted		287,564		9.65
Exercised		-		-
Forfeited/expired/cancelled		-		-
Outstanding at December 31, 2018		287,564		9.65

Exercisable at December 31, 2018		-	$	-

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables)

12 Months Ended

Dec. 31, 2018

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract]

Net Product Sales by Geographic Area

	For the years ended
	December 31, 2018		December 31, 2017
Africa	$	8,605,306	$	3,568,455
Asia		1,389,120		1,626,750
Europe & Middle East		2,172,031		1,763,274
Latin America		11,722,224		8,476,003
United States		2,852,339		3,887,820
	$	26,741,020	$	19,322,302

Long-lived Assets by Geographic Area

Long-lived assets by geographic area are as follows:

	2018		2017
Asia	$	466,185	$	472,774
Europe & Middle East		123,752		-
United States		2,283,983		1,436,458
	$	2,873,920	$	1,909,232

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Tables)

12 Months Ended

Dec. 31, 2018

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS [Abstract]

Future Minimum Salary Commitment

The following table is a schedule of future minimum salary commitments:

2019		$	485,493
2020			85,000

Future Minimum Rental Commitments

The following is a schedule of future minimum rental commitments for the years ending December 31,

2019	$	384,308
2020		88,576
2021		-
	$	472,884

Customer and Purchase Concentration Risks

	For the years ended										Accounts Receivable
	December 31, 2018					December 31, 2017					December 31, 2018		December 31, 2017
	Sales		% of Sales			Sales		% of Sales
Customer 1	$	11,171,174		42	%	$	8,065,217		42	%	$	3,499,340	$	-
Customer 2		4,346,640		16	%		-		-	%		1,033,824		-

The following table delineates purchases the Company had with vendors in excess of 10% of total purchases for the periods indicated:

For the years ended

Accounts Payable

December 31, 2018

December 31, 2017

December 31, 2018

December 31, 2017

Purchases

% of Purc.

Purchases

% of Purc.

Vendor 1

Vendor 2

746,868

Vendor 3

849,966

164,312

Vendor 4

1,646,614

884,698

In the tables above, an asterisk (*) indicates that purchases from the vendor did not exceed 10% for the period indicated.

ACQUISITIONS, opTricon (Details) - USD ($)		12 Months Ended
ACQUISITIONS, opTricon (Details) - USD ($)	Nov. 06, 2018	Dec. 31, 2018	Dec. 31, 2017
Business Combination, Consideration Transferred [Abstract]
Acquisition costs		$ 337,645	$ 58,076
Fair values of Assets Acquired and Liabilities Assumed [Abstract]
Goodwill		4,983,127	$ 1,666,610
Unaudited Pro Forma Operating Results [Abstract]
Total revenue		35,442,806
Net loss		$ (8,394,074)
Net loss per common share (in dollars per share)		$ (0.58)
Diluted net loss per common share (in dollars per share)		$ (0.58)
op Tricon [Member]
Business Combination, Consideration Transferred [Abstract]
Acquisition costs	$ 337,645
Fair values of Assets Acquired and Liabilities Assumed [Abstract]
Net current assets	404,204
Property, plant and equipment	125,000
Goodwill	3,337,000
Deferred tax liability	(635,000)
Other intangible assets (estimated useful life):
Other intangible assets	2,260,000
Total consideration	5,491,204
Unaudited Pro Forma Operating Results [Abstract]
Total revenue		$ 2,214,000
Net loss		213,000
Amortization of Intangible Assets		$ 351,000
op Tricon [Member] \| Developed Technology [Member]
Other intangible assets (estimated useful life):
Other intangible assets	$ 1,900,000
Weighted average useful life	7 years
op Tricon [Member] \| Customer Contracts / Relationships [Member]
Other intangible assets (estimated useful life):
Other intangible assets	$ 360,000
Weighted average useful life	10 years

ACQUISITIONS, RVR Diagnostics (Details) - USD ($)		12 Months Ended
ACQUISITIONS, RVR Diagnostics (Details) - USD ($)	Jan. 09, 2017	Dec. 31, 2018	Dec. 31, 2017
Business Combination, Consideration Transferred [Abstract]
Deposit for investments		$ 0	$ 850,000
Fair values of Assets Acquired and Liabilities Assumed [Abstract]
Goodwill		4,983,127	1,666,610
Other intangible assets (estimated useful life):
Total revenue		35,442,806
Net loss		$ (8,394,074)
RVR Diagnostics Sdn Bhd [Member]
Business Combination, Consideration Transferred [Abstract]
Cash payment	$ 1,400,000
Deposit for investments	$ 550,000
Shares issued (in shares)	269,236
Shares issued, value	$ 1,683,000
Shares held back (in shares)	7,277
Business acquisition transaction costs			25,000
Fair values of Assets Acquired and Liabilities Assumed [Abstract]
Property, plant and equipment	$ 235,141
Goodwill	1,651,361
Deferred tax liability	(307,636)
Contingent consideration	(148,000)
Other intangible assets (estimated useful life):
Other intangible assets	1,800,000
Total consideration	3,231,000
Total revenue			1,465,000
Net loss			$ (406,000)
RVR Diagnostics Sdn Bhd [Member] \| Intellectual Property [Member]
Other intangible assets (estimated useful life):
Other intangible assets	800,000
Weighted average useful life		10 years
RVR Diagnostics Sdn Bhd [Member] \| Customer Contracts / Relationships [Member]
Other intangible assets (estimated useful life):
Other intangible assets	700,000
Weighted average useful life		10 years
RVR Diagnostics Sdn Bhd [Member] \| Order Backlog [Member]
Other intangible assets (estimated useful life):
Other intangible assets	200,134
Weighted average useful life		3 months
RVR Diagnostics Sdn Bhd [Member] \| Trade Name [Member]
Other intangible assets (estimated useful life):
Other intangible assets	$ 100,000
Weighted average useful life		11 years

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Part 1 (Details) - USD ($)	1 Months Ended			12 Months Ended
	Apr. 30, 2017	Sep. 30, 2016	Aug. 31, 2016	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents				$ 12,524,551	$ 3,790,302	$ 10,554,464
License Agreements [Abstract]
Prepaid payments for license agreements				100,000	100,000
Amortization expenses				0	137,500
Valuation of Long-Lived Assets and Intangible Assets [Abstract]
Goodwill impairment loss				0	0
Disaggregation of Revenue [Abstract]
Total revenues				33,409,251	24,015,427
Contract Liabilities [Abstract]
Deferred revenue				422,905	$ 50,000
Earned grant revenue				$ 50,000
Loss Per Share [Abstract]
Options and warrants excluded from computation of earnings per share (in shares)				711,968	810,670
Fever Panel [Member]
Disaggregation of Revenue [Abstract]
Total revenues	$ 100,000
Contract Liabilities [Abstract]
Maximum amount of development agreement	1,000,000
Revenue from grants from inception	$ 900,000
Zika Virus [Member]
Disaggregation of Revenue [Abstract]
Total revenues			$ 2,600,000
Contract Liabilities [Abstract]
Maximum amount of development agreement			5,900,000
Revenue from grants from inception			$ 5,300,000
Bovid TB [Member]
Disaggregation of Revenue [Abstract]
Total revenues		$ 200,000
Contract Liabilities [Abstract]
Maximum amount of development agreement		700,000
Revenue from grants from inception		$ 500,000
Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				$ 30,377,003
Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				3,032,248
Africa [Member]
Disaggregation of Revenue [Abstract]
Total revenues				8,605,306
Asia [Member]
Disaggregation of Revenue [Abstract]
Total revenues				1,389,120
Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Total revenues				4,726,691
Latin America [Member]
Disaggregation of Revenue [Abstract]
Total revenues				11,722,224
United States [Member]
Disaggregation of Revenue [Abstract]
Total revenues				6,965,910
Net Product Sales [Member]
Disaggregation of Revenue [Abstract]
Total revenues				26,741,020	$ 19,322,302
Net Product Sales [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				26,741,020
Net Product Sales [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				0
Net Product Sales [Member] \| Africa [Member]
Disaggregation of Revenue [Abstract]
Total revenues				8,605,306	3,568,455
Net Product Sales [Member] \| Asia [Member]
Disaggregation of Revenue [Abstract]
Total revenues				1,389,120	1,626,750
Net Product Sales [Member] \| Europe & Middle East [Member]
Disaggregation of Revenue [Abstract]
Total revenues				2,172,031	1,763,274
Net Product Sales [Member] \| Latin America [Member]
Disaggregation of Revenue [Abstract]
Total revenues				11,722,224	8,476,003
Net Product Sales [Member] \| United States [Member]
Disaggregation of Revenue [Abstract]
Total revenues				2,852,339	3,887,820
License and Royalty Revenue [Member]
Disaggregation of Revenue [Abstract]
Total revenues				948,773	741,534
License and Royalty Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				948,773
License and Royalty Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				0
R&D, Milestone and Grant Revenue [Member]
Disaggregation of Revenue [Abstract]
Total revenues				5,719,458
R&D, Milestone and Grant Revenue [Member] \| Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				2,687,210
R&D, Milestone and Grant Revenue [Member] \| Non-Exchange Transactions [Member]
Disaggregation of Revenue [Abstract]
Total revenues				$ 3,032,248
Minimum [Member]
Fixed Assets [Abstract]
Estimated useful lives of fixed assets				3 years
Product Revenue [Abstract]
Revenue, payment terms				30 days
Maximum [Member]
Fixed Assets [Abstract]
Estimated useful lives of fixed assets				7 years
Product Revenue [Abstract]
Revenue, payment terms				60 days
Money Market Funds [Member] \| Level 1 [Member]
Cash and Cash Equivalents [Abstract]
Cash and cash equivalents				$ 4,700,000	$ 2,100,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Part 2 (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Goodwill and Intangible Assets [Assets]
Impairment of intangible assets	$ 0	$ 0
Goodwill [Roll Forward]
Goodwill, Beginning balance	1,666,610
Acquisition of opTricon	3,337,000
Changes in foreign currency exchange rate	(20,483)
Goodwill, Ending balance	4,983,127	1,666,610
Intangible assets [Abstract]
Accumulated Amortization	0	137,500
Net Book Value	3,884,831	1,597,377
Amortization Expense [Abstract]
Amortization expense	233,734	398,234
2019	496,512
2020	496,512
2021	496,512
2022	496,512
2023	496,512
Thereafter	$ 1,402,271
Intellectual Property [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	10 years
Developed Technology [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	7 years
Customer Contracts / Relationships [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	8 years
Order Backlog [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	0 years
Trade Name [Member]
Intangible assets [Abstract]
Weighted average remaining life of intangible assets	9 years
Plan [Member]
Recent Accounting Pronouncements Affecting the Company [Abstract]
Operating lease, right-of-use asset	$ 1,500,000
Operating lease, liability	1,500,000
OpTricon and CDM [Member]
Intangible assets [Abstract]
Cost	4,447,311	1,995,611
Accumulated Amortization	562,480	398,234
Net Book Value	3,884,831	1,597,377
OpTricon and CDM [Member] \| Intellectual Property [Member]
Intangible assets [Abstract]
Cost	1,089,688	886,872
Accumulated Amortization	173,633	88,687
Net Book Value	916,055	798,185
OpTricon and CDM [Member] \| Developed Technology [Member]
Intangible assets [Abstract]
Cost	1,910,315	0
Accumulated Amortization	0	0
Net Book Value	1,910,315	0
OpTricon and CDM [Member] \| Customer Contracts / Relationships [Member]
Intangible assets [Abstract]
Cost	1,121,600	776,013
Accumulated Amortization	151,929	77,601
Net Book Value	969,671	698,412
OpTricon and CDM [Member] \| Order Backlog [Member]
Intangible assets [Abstract]
Cost	217,187	221,867
Accumulated Amortization	217,187	221,867
Net Book Value	0	0
OpTricon and CDM [Member] \| Trade Name [Member]
Intangible assets [Abstract]
Cost	108,521	110,859
Accumulated Amortization	19,731	10,079
Net Book Value	$ 88,790	$ 100,780

INVENTORIES (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
INVENTORIES [Abstract]
Raw Materials	$ 2,803,677	$ 1,767,684
Work in Process	263,043	286,413
Finished Goods	4,784,502	2,369,521
Inventories	$ 7,851,222	$ 4,423,618

FIXED ASSETS (Details) - USD ($)	12 Months Ended
FIXED ASSETS (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Summary of fixed assets [Abstract]
Less: Accumulated Depreciation and Amortization	$ (6,463,784)	$ (5,804,800)
Fixed assets, net	2,873,920	1,909,232
Depreciation expense	634,261	727,563
Deposits on various pieces of equipment	428,859	257,455
Machinery and Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	6,070,137	4,582,759
Furniture and Fixtures [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	35,287	449,548
Computer Equipment [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	435,348	422,946
Leasehold Improvements [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	2,334,512	2,258,779
Enterprise Business Systems [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	462,420	$ 0
Capital Leases [Member]
Summary of fixed assets [Abstract]
Fixed assets, net	0
Equipment Undergoing Validation [Member]
Summary of fixed assets [Abstract]
Fixed assets, gross	$ 1,866,126

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract]
Accounts Payable - suppliers	$ 3,622,765	$ 1,494,759
Accrued Commissions	588,131	126,827
Accrued Royalties / license fees	279,213	429,297
Accrued Payroll	48,867	187,305
Accrued Vacation	264,789	309,767
Accrued Bonuses	494,318	282,500
Accrued Expenses - Other	590,598	215,848
Total	$ 5,888,681	$ 3,046,303

DEFERRED RESEARCH AND DEVELOPMENT REVENUE (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
DEFERRED RESEARCH AND DEVELOPMENT REVENUE [Abstract]
Deferred revenue	$ 422,905	$ 50,000

INCOME TAXES (Details) - USD ($)	12 Months Ended			24 Months Ended
INCOME TAXES (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2003	Dec. 31, 2005
Current [Abstract]
Federal	$ 0	$ (97,339)
State	10,914	9,034
Foreign	0	0
Total current (benefit) provision	10,914	(88,305)
Deferred [Abstract]
Federal	0	0
State	0	0
Foreign	(78,435)	0
Total deferred (benefit) provision	(78,435)	0
Total (benefit) provision	(67,521)	(88,305)
Income Taxes [Abstract]
Cumulative charge was fully offset by an equivalent adjustment to deferred tax valuation allowance	0	3,906,774
Cumulative benefit related to credit for ATM payment	0	(97,339)
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	27,303,044
Operating loss carryforwards, not subject to expiration	5,432,085
Components of Deferred Tax Assets and Liabilities [Abstract] [Abstract]
Inventory reserves	204,206	244,158
Accrued expenses	175,168	102,332
Net operating loss carry-forwards	7,122,576	5,800,144
Research and development credit	1,696,870	1,918,137
Stock-based compensation	215,797	167,522
Depreciation	139,362	91,258
Total deferred tax assets	9,553,979	8,323,551
Intangible	(968,849)	(341,042)
Total deferred tax liabilities	(968,849)	(341,042)
Net deferred tax assets before valuation allowance	8,585,130	7,982,509
Less valuation allowances	(9,477,438)	(8,323,551)
Net noncurrent deferred tax liabilities	(892,308)	(341,042)
Components of (loss) before income taxes [Abstract]
United States operations	(7,137,428)	(6,054,002)
International operations	(795,742)	(406,063)
(Loss) before taxes	$ (7,933,170)	$ (6,460,065)
Taxes [Abstract]
Federal income tax at statutory rates	21.00%	34.00%
State income taxes, net of federal benefit	(0.10%)	(0.09%)
Nondeductible expenses	(1.58%)	(1.04%)
Foreign rate differential	0.36%	(2.14%)
Change in valuation allowance	(18.44%)	(99.41%)
Impact of Tax Act on valuation allowance	0.00%	60.48%
AMT refund under Tax Act	0.00%	1.51%
Tax credits	0.00%	7.07%
Other	(0.39%)	0.99%
Income tax benefit	0.85%	1.37%
Income Tax Contingencies [Abstract]
Open tax year	2015 2016 2017 2018
State [Member]
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, subject to expiration	$ 1,784,554
Foreign [Member]
Tax Credit Carryforward [Abstract]
Operating loss carryforwards, not subject to expiration	$ 586,206

STOCKHOLDERS' EQUITY (Details) - USD ($)	1 Months Ended		12 Months Ended
STOCKHOLDERS' EQUITY (Details) - USD ($)	Nov. 30, 2018	Feb. 28, 2018	Dec. 31, 2018	Dec. 31, 2017
Common Stock [Abstract]
Underwritten public offering (in shares)	2,726,000	1,783,760
Underwritten exercise of overallotment (in shares)	355,565
Public offering price per share (in dollars per share)	$ 6.75	$ 6.75
Net proceeds after underwriting discounts and other offering expenses	$ 16,500,000	$ 10,900,000	$ 27,476,260	$ 0
Number of stock options exercised under the plan (in shares)			144,947	56,969
Exercised (in shares)			71,290	22,487
Exercise prices of stock option, minimum (in dollars per share)			$ 3.48	$ 3.48
Exercise prices of stock option, maximum (in dollars per share)			$ 5.64	$ 4.45
Preferred Stock [Abstract]
Preferred stock - shares authorized (in shares)			10,000,000	10,000,000
Preferred stock - shares outstanding (in shares)			0	0
Warrants [Abstract]
Warrants outstanding (in shares)			0	0

RIGHTS AGREEMENT (Details)	12 Months Ended
RIGHTS AGREEMENT (Details)	Dec. 31, 2018 Right
RIGHTS AGREEMENT [Abstract]
Number of preferred share purchase rights declared as dividend for each outstanding share of common stock	1
Minimum combined ownership of outstanding shares of common stock by acquiring person	20.00%

STOCK INCENTIVE PLANS, Part 1 (Details) - USD ($)		12 Months Ended
STOCK INCENTIVE PLANS, Part 1 (Details) - USD ($)	Sep. 22, 2011	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016	Dec. 31, 2018	Jun. 19, 2014	Jun. 03, 2008
Stock options, additional disclosure [Abstract]
Outstanding, aggregate intrinsic value, end of period		$ 687,364
Exercisable, aggregate intrinsic value, end of period		568,956
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense		$ 632,805	$ 384,897
Stock Options [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of stock options exercised under the plan (in shares)		144,947	56,969
Number of stock options outstanding under the plan (in shares)		810,670	600,549	600,549	711,968
Weighted average estimated grant-date fair value of stock options granted (in dollars per share)		$ 3.76	$ 2.77
Assumptions made in calculating fair values of options [Abstract]
Expected term		4 years 11 months 16 days	5 years 5 months 23 days
Expected volatility		39.91%	43.31%
Risk-free interest rate		2.70%	1.78%
Stock options, number of shares [Roll forward]
Outstanding, beginning of period (in shares)		810,670	600,549
Granted (in shares)		93,750	267,875
Exercised (in shares)		144,947	56,969
Forfeited/expired/cancelled (in shares)		47,505	785
Outstanding, end of period (in shares)		711,968	810,670	600,549
Exercisable, end of period (in shares)		396,799	371,295
Stock options, weighted average exercise price per share [Roll Forward]
Outstanding, beginning of period (in dollars per share)		$ 5.18	$ 4.55
Granted (in dollars per share)		9.80	6.40
Exercised (in dollars per share)		4.83	4.19
Forfeited/expired/cancelled (in dollars per share)		8.82	5.56
Outstanding, end of period (in dollars per share)		5.62	5.18	$ 4.55
Exercisable, end of period (in dollars per share)		$ 4.70	$ 4.44
Stock options, additional disclosure [Abstract]
Outstanding, weighted average remaining contract term		3 years 3 months 29 days	3 years 8 months 8 days	3 years 5 months 5 days
Exercisable, weighted average remaining contract term		2 years 7 months 28 days	2 years 7 months 13 days
Outstanding, aggregate intrinsic value, beginning of period		$ 2,477,853	$ 1,463,052
Granted, aggregate intrinsic value		352,220
Exercised, aggregate intrinsic value		523,327	100,018
Forfeited/expired/cancelled, aggregate intrinsic value		154,583
Outstanding, aggregate intrinsic value, end of period		687,364	2,477,853	$ 1,463,052
Exercisable, aggregate intrinsic value, end of period		$ 568,956	1,409,440
Net unrecognized compensation cost					$ 710,376
Weighted average period for recognition of net unrecognized compensation cost		2 years 5 months 12 days
Total fair value of stock options vested during period		$ 553,000
2008 Stock Incentive Plan [Member] \| Stock Options [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of shares authorized under the plan (in shares)	750,000						625,000
Increase in number of shares authorized (in shares)	125,000
Number of stock options exercised under the plan (in shares)		508,889
Number of stock options outstanding under the plan (in shares)		99,132			99,132
Options still available to be issued (in shares)					0
Stock options, number of shares [Roll forward]
Exercised (in shares)		508,889
Outstanding, end of period (in shares)		99,132
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 exercised under the plan (in shares)		85,407
Number of stock options outstanding under the plan (in shares)		405,968			405,968
Options still available to be issued (in shares)					21,061
Stock options, number of shares [Roll forward]
Exercised (in shares)		85,407
Outstanding, end of period (in shares)		405,968
2014 Stock Incentive Plan [Member] \| Restricted Stock [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of restricted shares awarded under the plan (in shares)		266,839
2014 Stock Incentive Plan [Member] \| Restricted Stock Units (RSUs) [Member]
Share-based Arrangements with Employees and Nonemployees [Abstract]
Number of restricted shares awarded under the plan (in shares)		20,725
Cost of Goods Sold [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense		$ 25,615	47,000
Research and Development Expense [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense		78,831	89,400
Selling, General and Administrative Expenses [Member]
Employee Service Share-based Compensation, Aggregate Disclosures [Abstract]
Allocated share-based compensation expense		$ 528,360	$ 248,497

STOCK INCENTIVE PLANS, Part 2 (Details) - USD ($)	12 Months Ended
STOCK INCENTIVE PLANS, Part 2 (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 3.48	$ 3.48
Range of exercise prices, maximum (in dollars per share)	$ 5.64	$ 4.45
Stock Options Outstanding [Abstract]
Shares outstanding (in shares)	711,968
Average remaining contract life	3 years 3 months 29 days
Weighted average exercise price (in dollars per share)	$ 5.62
Aggregate intrinsic value	$ 687,364
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)	396,779
Weighted average exercise price (in dollars per share)	$ 4.70
Aggregate intrinsic value	$ 568,956
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)	0
Average remaining contract life	0 years
Weighted average exercise price (in dollars per share)	$ 0
Aggregate intrinsic value	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)	0
Weighted average exercise price (in dollars per share)	$ 0
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)	304,343
Average remaining contract life	1 year 10 months 24 days
Weighted average exercise price (in dollars per share)	$ 3.45
Aggregate intrinsic value	$ 672,896
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)	254,343
Weighted average exercise price (in dollars per share)	$ 3.46
Aggregate intrinsic value	$ 560,711
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)	152,875
Average remaining contract life	3 years 5 months 5 days
Weighted average exercise price (in dollars per share)	$ 5.85
Aggregate intrinsic value	$ 14,468
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)	58,020
Weighted average exercise price (in dollars per share)	$ 5.80
Aggregate intrinsic value	$ 8,245
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)	207,875
Average remaining contract life	5 years 18 days
Weighted average exercise price (in dollars per share)	$ 7.31
Aggregate intrinsic value	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)	75,041
Weighted average exercise price (in dollars per share)	$ 7.21
Aggregate intrinsic value	$ 0
8.2 to 12 [Member]
Range of Exercise Prices [Abstract]
Range of exercise prices, minimum (in dollars per share)	$ 8.2
Range of exercise prices, maximum (in dollars per share)	$ 12
Stock Options Outstanding [Abstract]
Shares outstanding (in shares)	46,875
Average remaining contract life	4 years 7 months 6 days
Weighted average exercise price (in dollars per share)	$ 11.45
Aggregate intrinsic value	$ 0
Stock Options Exercisable [Abstract]
Shares exercisable (in shares)	9,375
Weighted average exercise price (in dollars per share)	$ 11.45
Aggregate intrinsic value	$ 0

STOCK INCENTIVE PLANS, Part 3 (Details) - USD ($)	12 Months Ended
STOCK INCENTIVE PLANS, Part 3 (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Weighted Average Grant Date Fair Value [Abstract]
Allocated share-based compensation expense	$ 632,805	$ 384,897
Restricted Stock and Restricted Stock Units [Member]
Number of Shares & Units [Abstract]
Outstanding, beginning of period (in shares)	0
Granted (in shares)	287,564
Exercised (in shares)	0
Forfeited/expired/cancelled (in shares)	0
Outstanding, end of period (in shares)	287,564	0
Exercisable (in shares)	0
Weighted Average Grant Date Fair Value [Abstract]
Outstanding, beginning of period (in dollars per share)	$ 0
Granted (in dollars per share)	9.65
Exercised (in dollars per share)	0
Forfeited/expired/cancelled (in dollars per share)	0
Outstanding, end of period (in dollars per share)	9.65	$ 0
Exercisable (in dollars per share)	$ 0
Net unrecognized compensation cost	$ 1,688,746
Weighted average period for recognition of net unrecognized compensation cost	2 years 6 months
Allocated share-based compensation expense	$ 281,249	$ 0

GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	$ 33,409,251	$ 24,015,427
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	2,873,920	1,909,232
Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	26,741,020	19,322,302
License and Royalty Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	948,773	741,534
R&D, Milestone and Grant Revenue [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	5,719,458
Africa [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	8,605,306
Africa [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	8,605,306	3,568,455
Asia [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	1,389,120
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	466,185	472,774
Asia [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	1,389,120	1,626,750
Europe & Middle East [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	4,726,691
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	123,752	0
Europe & Middle East [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	2,172,031	1,763,274
Latin America [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	11,722,224
Latin America [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	11,722,224	8,476,003
United States [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	6,965,910
Geographic Areas, Long-Lived Assets [Abstract]
Long-lived assets	2,283,983	1,436,458
United States [Member] \| Net Product Sales [Member]
Geographic Areas, Revenues from External Customers [Abstract]
Net sales	$ 2,852,339	$ 3,887,820

COMMITMENTS, CONTINGENCIES AND CONCENTRATIONS (Details)

12 Months Ended

Dec. 31, 2018

USD ($)

KeyEmployee

Lease

Dec. 31, 2017

USD ($)

Employment Contracts [Abstract]

Number of key employees with whom Company has employment contracts | KeyEmployee

Aggregate annual salaries of employment contracts

$ 770,000

Contract one, expiration date

Mar. 31, 2019

Contract two, expiration date

Mar. 31, 2020

Future minimum salary commitments [Abstract]

2019

$ 485,493

2020

$ 85,000

Pension Plan [Abstract]

Percentage of employer's matching contribution

40.00%

$ 94,544

$ 91,150

Schedule of future minimum rental commitments [Abstract]

384,308

88,576

472,884

653,155

586,730

Economic Dependency [Abstract]

Net sales

33,409,251

24,015,427

Accounts Receivable

7,373,971

2,085,340

Purchases

21,427,243

12,921,157

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

Economic Dependency [Abstract]

Accounts Receivable

3,499,340

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

Economic Dependency [Abstract]

Accounts Receivable

1,033,824

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

Economic Dependency [Abstract]

Accounts Payable

^[1]

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

Economic Dependency [Abstract]

Accounts Payable

^[1]

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

Economic Dependency [Abstract]

Accounts Payable

^[1]

Supplier Concentration Risk [Member] | Vendor 4 [Member]

Economic Dependency [Abstract]

Accounts Payable

$ 164,312

^[1]

Maximum [Member]

Pension Plan [Abstract]

Employee contribution subject to employer matching contribution

5.00%

Employer matching contribution

2.00%

Medford [Member]

Lease, Amount [Abstract]

Monthly rent

$ 30,140

Lease expiration date

Apr. 30, 2019

Percentage of monthly rent increase in year three through five

2.50%

Holbrook [Member]

Lease, Amount [Abstract]

Monthly rent

$ 16,709

Lease expiration date

Apr. 30, 2020

Percentage of monthly rent increase in year three through five

3.00%

Kuala Lumpur [Member]

Lease, Amount [Abstract]

Monthly rent

$ 5,400

Lease expiration date

Apr. 30, 2020

Number of separate leases | Lease

Number of additional year of renewal option

3 years

Germany [Member]

Lease, Amount [Abstract]

Monthly rent

$ 13,445

Percentage of monthly rent increase in year three through five

2.00%

Sales [Member] | Customer Concentration Risk [Member]

Economic Dependency [Abstract]

Concentration risk percentage

10.00%

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

Economic Dependency [Abstract]

Concentration risk percentage

42.00%

Net sales

$ 11,171,174

$ 8,065,217

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

Economic Dependency [Abstract]

Concentration risk percentage

16.00%

0.00%

Net sales

$ 4,346,640

$ 0

Purchases [Member] | Supplier Concentration Risk [Member]

Economic Dependency [Abstract]

Concentration risk percentage

10.00%

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

Economic Dependency [Abstract]

Concentration risk percentage

^[1]

Purchases

^[1]

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

Economic Dependency [Abstract]

Concentration risk percentage

^[1]

12.00%

Purchases

^[1]

$ 746,868

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

Economic Dependency [Abstract]

Concentration risk percentage

^[1]

14.00%

Purchases

^[1]

$ 849,966

Purchases [Member] | Supplier Concentration Risk [Member] | Vendor 4 [Member]

Economic Dependency [Abstract]

Concentration risk percentage

16.00%

14.00%

Purchases

$ 1,646,614

$ 884,698

[1]	Purchases from the vendor did not exceed 10% for the period indicated.

NOTE PAYABLE (Details) - Note Payable - Equipment Vendor [Member] - USD ($)	1 Months Ended	12 Months Ended
	Sep. 30, 2017	Dec. 31, 2018
Debt Instruments [Abstract]
Debt instrument, face amount	$ 660,000
Percentage of first prepayment of the term	30.00%
Percentage of second prepayment of the term	60.00%
Percentage of prepayment after delivery	10.00%
Percentage of first prepayment of the term by the vendor	15.00%
Percentage of second prepayment of the term by the vendor	40.00%
Percentage of prepayment after delivery by the vendor	10.00%
Annual interest rate	12.00%
Periodic payment debt instrument, principal and interest	$ 20,150
Term of debt instrument		24 months

SUBSEQUENT EVENTS (Details) - Subsequent Event [Member]	Feb. 05, 2019 USD ($) ft² Term
Hauppauge [Member]
Leases [Abstract]
Lease of office space \| ft²	70,000
Initial lease term	11 years
Number of additional terms that lease term can be extended \| Term	2
Initial lease term extension for each term	5 years
Rent under lease	$ 900,000
Approximate percentage increase in rent per year	3.00%
Security deposit and payment of four months base rent	$ 450,000
Free rent period	9 months
Holbrook [Member]
Leases [Abstract]
Percentage of rent receivable from sublessee	50.00%
Sublease rent	$ 100,000