SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported) January
19, 2006
CHEMBIO
DIAGNOSTIC, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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0-30379
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88-0425691
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer
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of
Incorporation)
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Identification
Number)
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3661
Horseblock Road
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Medford,
NY 11763
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(Address
of principal executive offices)
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631-924-1135
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(Registrant’s
Telephone Number)
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N/A
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
2.02. Results of Operations and Financial Condition.
(a) To
the
extent applicable, the information disclosed under Item 7.01 is
incorporated herein by reference.
ITEM
7.01. Regulation FD Disclosures.
(a) On
January 19, 2006 the Registrant issued the press release titled “Chembio
Receives $1.2 Million Order for Chagas STAT-PAK(TM) Rapid Test As Demand
Accelerates for Rapid Detection of Infectious Diseases” included herein as
Exhibit 99.1.
ITEM
9.01. Financial Statements and Exhibits
(c) Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date:
January 23, 2006 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Chembio
Receives $1.2 Million Order for Chagas STAT-PAK(TM) Rapid Test As Demand
Accelerates for Rapid Detection of Infectious Diseases
Company
Expects 2006 Revenues to Increase Significantly
MEDFORD,
N.Y. - January 19, 2006 - Chembio Diagnostics Inc. (OTCBB:CEMI) has received
a
$1.2 million purchase order for its Chagas STAT-PAK(TM) rapid test. The purchase
order is from a leading Pan-American public health organization and is to
supply
the National Chagas Program that has been established by Bolivia’s Ministry of
Health. Chembio’s Chagas STAT-PAK(TM) will be used to screen children in areas
of Bolivia where this parasitic infectious disease is most endemic. Deliveries
are to be made through the first seven months of 2006.
Lawrence
Siebert, President and CEO of Chembio Diagnostics, Inc. commented, “This is our
first significant order for Chagas STAT-PAK(TM). We believe that these revenues
from Chagas STAT-PAK(TM), combined with continued expected increases in the
worldwide sales of our rapid HIV tests, will result in 2006 revenues that
will
be significantly greater than the preliminary $3.93 million we recently reported
for the 2005 fiscal year. We believe that these additional revenues will
also
result in higher gross margins.”
Chembio’s
Chagas STAT-PAK(TM) rapid test will screen individuals for one of the world’s
most deadly but also most neglected diseases, a disease that affects an
estimated 16 million adults and children worldwide. Once Chagas is detected,
drug therapy is available that can treat infected children, but only if given
to
children age fourteen or younger. An estimated 25% of the Latin American
population (nearly 100 million people) is at risk in 21 countries. Chagas
is
also becoming a growing concern for the U.S. and Europe as immigration increases
from these endemic areas.
Avi
Pelossof, Chembio’s Vice President of Sales, Marketing and Business Development,
commented, “We are pleased that through the use of Chembio’s Chagas STAT-PAK(TM)
rapid test in rural and remote areas of Bolivia, many children may be spared
from developing this debilitating and often fatal disease. In addition, we
are
confident in the value that our Chagas STAT-PAK(TM) test brings to public
health
in identifying many infected individuals who are not aware of their
status.”
Chagas
is
transmitted by Trypanosoma cruzi,
a
protozoan parasite. Infection occurs when an infected insect bites its mammalian
host and releases infective trypomastigotes in its excreta while feeding.
Alternatively, infection can occur through blood transfusions, organ
transplantation, ingestion of contaminated food and congenitally. Chagas
is
directly responsible for an estimated 50,000 deaths per year.
The
Chagas STAT-PAK(TM) assay is a rapid test that detects antibodies to Trypanosoma
cruzi.
It
employs a unique antigen cocktail that provides high sensitivity and
specificity. The test is simple to perform and provides results in 15 minutes.
No special equipment is required and the assay does not require refrigeration.
A
study in the October 2005 issue of the Journal of Clinical Microbiology reported
that the Chagas STAT-PAK(TM) assay had 99.6% and 99.9% sensitivity and
specificity, respectively, when assayed with 5,998 samples. This study was
performed with samples from different blood centers in Central America.
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. (Chembio) possesses expertise in the development and
manufacturing of rapid test products for various infectious diseases, including
HIV, Tuberculosis
and
Chagas Disease. References to Chembio Diagnostics, Inc. may actually refer
to
Chembio Diagnostic Systems, Inc.; the 100%-owned subsidiary of Chembio
Diagnostics, Inc. Chembio is located at 3661 Horseblock Road, Medford, NY
11763.
FORWARD-LOOKING
STATEMENTS
Statements
contained herein that are not historical facts may be forward-looking statements
within the meaning of the Securities Act of 1933, as amended. Forward-looking
statements include statements regarding the intent, belief or current
expectations of the Company and its management and statements concerning
the
Company’s preliminary estimates for the periods ended December 31, 2005
discussed herein. Such statements are estimates only, as the Company has
not
completed the preparation of its financial statements for those periods,
nor has
its auditor completed the audit of those results. Actual revenue may differ
materially from those anticipated in this press release. Such statements
reflect
management's current views, are based on certain assumptions and involve
risks
and uncertainties. Actual results, events, or performance may differ materially
from the above forward-looking statements due to a number of important factors,
and will be dependent upon a variety of factors, including, but not limited
to
Chembio's ability to obtain additional financing, to obtain regulatory approvals
in a timely manner, and the demand for Chembio's products. Chembio undertakes
no
obligation to publicly update these forward-looking statements to reflect
events
or circumstances that occur after the date hereof or to reflect any change
in
Chembio's expectations with regard to these forward-looking statements or
the
occurrence of unanticipated events. Factors that may impact Chembio's success
are more fully disclosed in Chembio's most recent public filings with the
U.S.
Securities and Exchange Commission.
Contact:
Vince
Daniels/James Carbonara
The
Investor Relations Group 212-825-3210