Chembio's SURE CHECK(R) HIV 1/2 Assay for Rapid Point-of-Care Detection of HIV
Receives CE Mark Approval
Sales of SURE CHECK(R) HIV 1/2 Assay in Europe Anticipated by Q1 2014
MEDFORD, N.Y., June 18, 2013 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc.
(Nasdaq:CEMI) a leader in point-of-care ("POC") diagnostic tests for
infectious diseases, announced today that it's SURE CHECK® HIV 1/2 Assay has
received CE Mark approval from European regulators. The SURE CHECK® HIV 1/2
Assay is now cleared for commercialization within the European Union (EU) for
rapid, point-of-care detection of HIV.This product is FDA-approved and
distributed in the U.S. as Clearview® COMPLETE HIV 1/2by Alere NA.Chembio is
currently working with commercialization partners in Europe and expects sales
of the SURE CHECK® HIV 1/2 Assay in the EU by Q1 2014.
France alone reported the administration of 5.2 million HIV tests
(serological) in 2012.According to the European Centre for Disease Prevention
and Control and the World Health Organization Regional Office for Europe,
there were more than 28,000 new HIV diagnoses in 2011 in the EU and European
Economic Area (EEA).The 2011 European HIV/AIDS surveillance report published
by these groups concluded, "HIV infection is of major public health importance
in Europe, with evidence of continuing transmission in specific populations
with no clear signs of overall decrease."
"Chembio is dedicated to the development of superior diagnostics to enable
rapid detection and early treatment of HIV and other infectious diseases,"
stated Lawrence A. Siebert, chairman and CEO of Chembio."This CE Mark allows
us the opportunity to bring these important diagnostics to the European
market, an area that continues to see a rise in HIV among certain significant
populations.We are working with commercialization groups to support our
launch of the SURE CHECK® HIV 1/2 Assay in Europe in the coming months.In
addition, we continue to work with regulators in Europe to obtain CE Marks for
several of our other diagnostic products this year including, our HIV 1/2
STAT-PAK® test, DPP® HIV 1/2 Oral Fluid test and DPP® Syphilis test."
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 more
information, please visit: www.chembio.com.
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
(631) 924-1135, ext. 125
Vida Strategic Partners (investors)
Stephanie C. Diaz
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