Chembio Receives FDA Approval for DPP(R) Point-of-Care HIV 1/2 Rapid Test

Chembio Receives FDA Approval for DPP(R) Point-of-Care HIV 1/2 Rapid Test

MEDFORD, N.Y., Dec. 21, 2012 (GLOBE NEWSWIRE) -- 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™, 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
         (631) 924-1135, ext. 125
         snorcott@chembio.com
        
         LHA
         Anne Marie Fields
         (212) 838-3777
         AFields@lhai.com
         @LHA_IR_PR
 
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