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
13, 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.
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(a)
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On
March 13, 2006 the Registrant issued the press release titled “Chembio
Supports Regulatory Path Recommended By FDA Committee for Approval
of Over
the Counter Rapid HIV Tests” included herein as Exhibit
99.1.
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(b)
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On
March 14, 2006 the Registrant issued the press release titled “Chembio
Diagnostics Appoints Dr. Mariano Levin, An Expert in Chagas and
Other
Neglected Diseases, to Advisory Board” included herein as Exhibit
99.2.
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ITEM
9.01. Financial Statements and Exhibits
(c) Exhibits.
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99.1
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Press
Release titled “Chembio Supports Regulatory Path
Recommended By FDA Committee for Approval of Over the Counter Rapid
HIV
Tests” issued March 13, 2006.
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99.2
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Press
Release titled “Chembio Diagnostics Appoints Dr.
Mariano Levin, An Expert in Chagas and Other Neglected Diseases,
to
Advisory Board” issued March 14,
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 15, 2006 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release 3/13/06
Chembio
Supports Regulatory Path Recommended By FDA Committee for Approval of Over
the
Counter Rapid HIV Tests
MEDFORD,
N.Y. - March 13, 2006 - Chembio
is pleased by the recommendation that was given to the Food & Drug
Administration (FDA) by FDA’s Blood Products Advisory Committee (BPAC) on
Friday, March 10 concerning proposed regulatory requirements for the approval
of
over the counter (OTC) distribution of rapid HIV tests.
The
BPAC
was unanimous in its recommendation that products that are or become approved
by
the FDA for professional use would automatically meet the analytical sensitivity
and specificity requirements that are part of the first of three phases of
requirements that BPAC recommended for OTC distribution. Chembio is expecting
professional market approval of two of its three rapid HIV tests, HIV 1/2
STAT-PAK™ and SURE CHECK® HIV during the first half of this year. The main
additional recommended requirements will be for studies to ensure that untrained
users, in both controlled and intended use settings, will be able to properly
perform the tests, interpret results, and fully understand the informational
materials that will be required to accompany each test kit, which will include
information regarding access to counseling and treatment.
Chembio’s
CEO Lawrence Siebert, who attended the hearing with Avi Pelossof, Chembio’s VP
Sales, Marketing and Business Development, said: “Possible U.S. OTC approval
opens up a new potential market for our products, one that should help identify
those HIV-positive individuals in the U.S. who are unaware of their status.”
Avi
Pelossof said: “Our goal is to make HIV rapid tests more accessible. The OTC
market will provide more options for those wishing to learn their HIV status.
Chembio’s ability to produce
high quality, multi-platform products that are also competitively priced
and
have a 24 month shelf-life should be a significant advantage in the OTC market.”
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. (OTCBB: CEMI) 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:
IR: Vince
Daniels/James Carbonara
PR:
Judy
Katz
The
Investor Relations Group 212-825-3210
Chembio
Diagnostics Appoints Dr. Mariano Levin,
An
Expert in Chagas and Other Neglected Diseases, to Advisory Board
MEDFORD,
N.Y. - March 14, 2006 - Chembio Diagnostics Inc. (OTCBB: CEMI) has appointed
Dr.
Mariano Jorge Levin, a leading expert on Chagas Disease, to its Advisory Board.
Dr.
Levin
is head of the Laboratory of Molecular Biology of Chagas Disease at the
Institute for Research on Genetic Engineering and Molecular Biology in Buenos
Aires, Argentina. He received a Ph.D. in biochemistry in 1981 from the
University of Leipzig, Germany and conducted postdoctoral work in France at
INSERM, CNRS, and Institut Pasteur. He has received several prizes from the
Argentine Society of Cardiology, and, in 1998 was awarded a John Simon
Guggenheim Foundation fellowship. He is currently a Howard Hughes International
Research Scholar. As Full Professor at the School of Science and with the
support of the Howard Hughes Medical Institute and the University of Buenos
Aires, he created and directs the first genomic facility of this University,
CeGA (Center of Applied Genomics). He is also a member of the Board of the
South
South Initiative (SSI) of the World Health Organization Special Program for
Research and Training in Tropical Diseases (WHO - TDR), and the coordinator
in
the field of Trypanosomiases, including Chagas Disease and African Sleeping
Sickness.
“We
are
delighted to have an individual of Dr. Levin’s distinction and expertise on our
Advisory Board," said Larry Siebert, Chairman and President of Chembio.
Earlier
this year Chembio received a $1.2 million order for Chagas STAT-PAK™, a rapid
test for this largely neglected yet deadly infectious disease that affects
some
18 million people. The test incorporates a cocktail of recombinant antigens
that
have been exclusively licensed to Chembio.
*
* *
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. (OTCBB: CEMI) 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