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Positive Data From Independent Study of Chembio Diagnostics' Rapid, Point-of-Care Syphilis Test Published in Clinical Infectious

Positive Data From Independent Study of Chembio Diagnostics' Rapid,
Point-of-Care Syphilis Test Published in Clinical Infectious Diseases

Test Accurately Detects Both Nontreponemal and Treponemal Antibodies

MEDFORD, N.Y., Dec. 6, 2012 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc.
(Nasdaq:CEMI), a leader in point-of-care diagnostic tests for infectious
diseases, reported today that data from a study evaluating performance
characteristics (sensitivity and specificity) of the Company's patented Dual
Path Platform (DPP^®) rapid point-of-care (POC) test for syphilis was recently
published online in Clinical Infectious Diseases and is expected to be
published in the upcoming print edition. DPP^® Syphilis Screen and Confirm is
the first dual non-treponemal (screen for infection) and treponemal (confirms
an active syphilis infection if non-treponemal is reactive) POC syphilis test
that permits the simultaneous yet separate detection of both markers at the
POC. The study authors concluded that DPP® Syphilis Screen and Confirm
demonstrated good sensitivity and specificity in detecting treponemal and
non-treponemal antibodies in three kinds of blood specimens. The complete
article, "A dual point-of-care test shows good performance in simultaneously
detecting nontreponemal and treponemal antibodies in patients with syphilis –
A multi-site evaluation study in China," can be accessed online at
http://cid.oxfordjournals.org/content/early/2012/10/29/cid.cis928.abstract.

The study was supported by a grant from the Rapid Syphilis Test Introduction
Project (UNICEF/UNDP/World Bank/WHO Special Programme for Research and
Training in Tropical Diseases A70577 through a grant from the Bill & Melinda
Gates Foundation).

Lawrence Siebert, Chembio's Chief Executive Officer, noted, "These data
independently confirm the high sensitivity and specificity of our DPP^®
Syphilis Screen and Confirm rapid assay in patients with syphilis.The
simultaneous detection of treponemal and non-treponemal antibodies offers the
opportunity to increase coverage of syphilis screening and
treatment.Currently, there is no single FDA-approved point-of-care test for
syphilis that differentiates between active and past, or previously treated
cases, and there continues to be a substantial interest in this product by
public health groups in the United States and abroad."

According to the U.S. Centers for Disease Control and Prevention (CDC), "The
use of only one type of serologic test is insufficient for diagnosis because
each type of test has limitations, including the possibility of false-positive
test results in persons without syphilis. False-positive nontreponemal test
results can be associated with various medical conditions unrelated to
syphilis, including autoimmune conditions, older age and injection-drug use;
therefore, persons with a reactive nontreponemal test should receive a
treponemal test to confirm the diagnosis of syphilis."

Mr. Siebert added, "We believe these positive data will be helpful in
supporting our U.S. regulatory filing for DPP Syphilis Screen and Confirm, for
which we are pursuing a de novo 510(k) regulatory pathway with the U.S. Food
and Drug Administration (FDA).We are in discussion with the FDA to review
these and other data and then to re-initiate clinical trials and submit our
application by the middle of 2013."

According to the CDC, syphilis is a sexually transmitted disease caused by the
bacterium Treponema pallidum. Syphilis can cause long-term complications
and/or death if not adequately treated.In 2010 there were 45,834 new cases of
syphilis in the U.S., of which, 13,774 were primary and secondary syphilis,
the earliest and most transmissible stages of syphilis. The World Health
Organization estimated that 11 million new cases of syphilis occurred in
adults in 2005, the majority of them in developing countries.

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.

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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