Chembio Diagnostics to Present at the FDA Blood Products Advisory Committee on November 17, 2009

MEDFORD, NY, Nov 17, 2009 (MARKETWIRE via COMTEX) --
CEMI | Quote | Chart | News | PowerRating -- Chembio Diagnostics, Inc. (OTCBB: CEMI), a company that develops,
manufactures, licenses, and markets proprietary rapid diagnostic
tests, announced today that it will present at a meeting of the Blood
Products Advisory Committee ("BPAC") of the U.S. Food and Drug
Administration ("FDA") in Bethesda, Maryland, on the afternoon of
November 17, 2009. The agenda of the committee will include the public
health need and performance characteristics of over-the-counter
("OTC") home-use HIV test kits.

Chembio's presentation will be made by Louise Sigismondi, Ph.D.,
Director of Regulatory Affairs at Chembio, who will cover certain
characteristics of Chembio's DPP(R) HIV 1/2 Screening Assay,
particularly those which could make it suitable as an OTC HIV test
kit intended for home use. This product is a rapid, qualitative
screening assay for the detection of antibodies to HIV 1 & 2 in oral
fluids, whole blood, serum or plasma. The simple-to-use test offers a
very reliable result within minutes of administration and it can be
safely stored at room temperature for up to 24 months before use,
making it ideal for the OTC market. Chembio intends to seek
regulatory approval for this product for the professional market in
the U.S. during 2010. Depending on various factors, including the
FDA requirements, Chembio intends to begin seeking OTC approval of
this product in 2011.

Lawrence Siebert, CEO of Chembio, said, "Possible U.S. OTC approval
of this test 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, and we look forward to providing the
BPAC with information about our technology and to receiving further
guidance from BPAC regarding the requirements for obtaining approval
of this product in the OTC market."

Further information concerning this meeting can be accessed at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM189020.pdf.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and
markets proprietary rapid diagnostic tests in the growing $5 billion
point-of-care testing market. Chembio's two FDA PMA-approved,
CLIA-waived, rapid HIV tests are marketed in the U.S. by Inverness
Medical Innovations, Inc. Chembio markets its HIV STAT-PAK(R) line of
rapid HIV tests internationally to government and donor-funded
programs directly and through distributors. Chembio has developed a
patented point-of-care test platform technology, the Dual Path
Platform (DPP(R)) technology, which has significant advantages over
lateral-flow technologies. This technology is providing Chembio with
a significant pipeline of business opportunities for the development
and manufacture of new products based on DPP(R). Headquartered in
Medford, NY, with approximately 100 employees, Chembio is licensed by
the U.S. Food and Drug Administration (FDA) as well as the U. S.
Department of Agriculture (USDA), and is certified for the global
market under the International Standards Organization (ISO) directive
13.485.

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 a review or 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.

Contacts:

Company:
Susan Norcott
631-924-1135 x125
snorcott@chembio.com

The Investor Relations Group:
Investor Relations:
James Carbonara
212-825-3210

Media Relations:
Enrique Briz
212-825-3210

SOURCE: Chembio Diagnostics, Inc.

mailto:snorcott@chembio.com

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