Chembio Diagnostics Inc (CEMI)

[Hegotgame]

MEDFORD, N.Y., Dec 21, 2012 (GLOBE NEWSWIRE via COMTEX) -- Chembio Diagnostics,
Inc. (Nasdaq:CEMI),a leader in point-of-care diagnostic tests for infectious
diseases, announces receipt of approval from the U.S. Food and Drug
Administration (FDA) to market the Company's Dual Path Platform (DPP) HIV 1/2
assay for the rapid, point-of-care (POC) detection of HIV-1/2 antibodies in
either oral fluid or blood samples. This determination follows a review of
Chembio's Premarket Approval (PMA) application and marks the first FDA approval
of a diagnostic assay utilizing the Company's patented Dual Path Platform
technology. DPP enables samples to bind directly with target analytes before
detection reagents are introduced to visualize the test results, and can improve
accuracy compared with the current lateral flow HIV test technologies.

"We are very proud to receive FDA approval to market our DPP HIV 1/2 Assay,
which allows us to commercialize a POC oral fluid rapid diagnostic test that we
believe has superior performance compared with the only other oral fluid HIV
rapid test on the market," noted Lawrence Siebert, Chembio's Chief Executive
Officer. "With more than 1.2 million Americans estimated to be living with HIV
and approximately 20% of them unaware they are infected with the virus, rapid
HIV tests are playing a critical role in the U.S., as they have globally, to
help identify those with HIV and to prevent disease transmission. In addition,
the market for these tests is expected to grow significantly with the recent
recommendations by the U.S. Preventive Services Task Force to mandate insurance
reimbursement for routine HIV testing."

Chembio's DPP point-of-care HIV 1/2 Assay detects antibodies to HIV-1 and HIV-2
in oral fluid, fingerstick whole blood, venous whole blood, serum or plasma
samples, and provides a simple "reactive/non-reactive" result. In a multi-site
clinical study of approximately 2,800 patients across five clinical settings,
including a pediatric hospital, the diagnostic sensitivity of the assay to
detect HIV infection resulted in sensitivity of 99.8% for fingerstick samples;
99.9% for venous whole blood, serum and plasma samples; and 98.9% for oral fluid
samples. The specificity of the assay was 100% for fingerstick specimens; and
99.9% for oral fluid, venous whole blood, plasma and serum samples. The test is
intended to be used in the preliminary diagnosis of patients with HIV in
point-of-care settings such as public health and other clinics, hospital
emergency rooms and physician offices.

The DPP point-of-care HIV 1/2 Assay is the only rapid test in the U.S. that does
not use lateral flow or other older flow-through technologies. DPP HIV 1/2 is
approved to detect HIV in patients two years of age and older, which is also a
differentiating feature compared with all other rapid assays that are approved
only to detect HIV in patients 13 years of age and older. DPP HIV 1/2 delivers
visual results within 15 minutes, is simple to use, requires minimal sample
size, has a shelf life of 24 months and does not require refrigeration. DPP HIV
1/2 features a comfortable swab for collecting oral fluid samples and provides
sharp, distinct test lines due to the DPP technology. In addition, a proprietary
sample collection system enables each sample to be contained in a convenient,
closed collection vial, or Sampletainer(TM), which may provide additional sample
for repeat testing, allowing greater testing flexibility over other systems that
do not have separate sample collection or that use open vials for stirring blood
samples.

"As we finalize our commercial strategy for the launch of this new DPP assay in
the U.S, we will be conducting and submitting our Clinical Laboratory
Improvement Amendments (CLIA) waiver trials in order to establish the quality
standards for our laboratory testing that provide for the accuracy, reliability
and timeliness of patient tests results regardless of where the tests are
performed," added Mr. Siebert. "We plan to make this submission during the first
half of 2013 and expect to launch DPP HIV 1/2 in the U.S. during the second half
of 2013."

For more information about the Company's DPP point-of-care HIV 1/2 Rapid Assay,
Chembio has animated video, poster presentations and publications available on
its website at: http://chembio.com/products/human-diagnostics/dpp-hiv-12-assay/.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets
proprietary rapid diagnostic tests in the growing $10 billion point-of-care
testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are
marketed in the U.S. by Alere, Inc. (formerly, Inverness Medical Innovations,
Inc.). Chembio markets its HIV STAT-PAK 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) 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. Headquartered in Medford, NY, with
approximately 170 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. For additional information, please visit
the Company's website at 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, which
are estimates only, 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 and to obtain regulatory approvals in a timely manner, as well as 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: Chembio Diagnostics

Susan Norcott

[phone], ext. 125

[e-mail]



LHA

Anne Marie Fields