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) March
21, 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
7.01. Regulation FD Disclosures.
On
March
21, 2006 the Registrant issued the press release titled “Chembio Edges Closer to
Entering the $50 Million Veterinary TB Market” included herein as Exhibit
99.1.
ITEM
9.01. Financial Statements and Exhibits
(c) Exhibits.
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99.1
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Press
Release titled “Chembio Edges Closer to Entering
the $50 Million Veterinary TB Market” issued March 21,
2006.
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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:
March 21, 2006 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 - Press Release 3/20/06
Chembio
Edges Closer to Entering the $50 Million Veterinary TB
Market
MEDFORD,
N.Y. - March 21, 2006 - Chembio Diagnostics, Inc. (OTCBB:CEMI), has made
substantial progress towards the launch of its PrimaTB STAT-PAK(TM) rapid
test
and pending completion of the external reproducibility studies and USDA facility
inspection and licensure, plans commercial release of the test in late 2006.
The
test is for simple and rapid detection of Tuberculosis (TB) in non-human
primates (NHP). TB in both captive and wild animals is a significant problem
in
the US, Europe and Japan, and more effective diagnostic tools are needed.
Economic costs range from loss of whole NHP colonies used in research to
loss of
TB-free status amongst cattle herds, potentially halting dairy and meat
processing activities. Currently available veterinary TB diagnostic tests
are
inaccurate, cumbersome and time-consuming to perform and to obtain
results.
In
addition to its PrimaTB STAT-PAK, Chembio is completing a series of veterinary
TB rapid tests for other animals such as cattle, deer, camels, elephants
and
other exotic species. The veterinary TB product was recently awarded US Animal
Health Association recommendation for conditional approval for use in bovids,
cervids, elephants, and other exotic animals. Pending completion of clinical
trials and receipt of USDA licensure, these various VetTB STAT-PAK assays
are
currently planned for commercial release in early 2007. Chembio believes
that
the NHP and VetTB products combined address a market estimated to be $50
million.
These
tests are all based on the detection of TB antibodies from whole blood (as
well
as serum or plasma) reacting to a cocktail of carefully selected recombinant
TB
antigens and offer a number of advantages over current standard skin testing.
These include ease of use, portability, rapid results (in less than 20 minutes),
minimal invasiveness, better sensitivity and specificity, and anticipated
lower
associated labor costs. These features in PrimaTB STAT-PAK will benefit
pharmaceutical companies, clinical research organizations, and large primate
suppliers and national primate research centers.
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. possesses
expertise in the development and manufacturing of rapid diagnostic tests
for
various infectious diseases. Chembio
is participating in the frontlines of the global battle against the devastating
AIDS pandemic. This battle, to which the United States alone has pledged
$15
billion in international aid, is the impetus behind Chembio’s rapid HIV tests.
Because rapid tests can detect HIV antibodies within minutes, the massive
prevention and treatment programs that are now scaling up can be much more
effective. Chembio is one of four global rapid HIV test suppliers under the
Clinton HIV/AIDS Initiative (www.clintonfoundation.org). The Company also
manufactures additional rapid tests that it has developed for other deadly
diseases, including human and veterinary Tuberculosis and Chagas Disease.
References
to Chembio Diagnostics, Inc. may actually refer to Chembio Diagnostic Systems,
Inc.; the wholly owned subsidiary of Chembio Diagnostics, Inc. Chembio is
located at 3661 Horseblock Road, Medford, NY 11763. For additional information
please visit www.chembio.com.
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. 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