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Chembio's DPP(R) HIV 1/2 Assay Receives CE Mark Approval for Rapid Point-of-Care Detection of HIV

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Chembio Diagnostics, Inc.
(Nasdaq: CEMI), a leader in point-of-care ("POC") diagnostic tests for
infectious diseases, announced today that it has received approval for a CE
Mark for its DPP(R) HIV 1/2 Assay. The Chembio DPP(R) HIV 1/2 Assay for
rapid, POC detection of HIV is now cleared for commercialization and sale
within the 28 member states of the European Union.
According to multiple international health and surveillance agencies, an
estimated 2.3 million people are living with HIV in the member states of the
European Union with at least one in three infected people being unaware of
their status. According to recent reports, as many as 50% of those infected
with HIV in the member states of the European Union are diagnosed late,
after symptoms emerge, and approximately one-half of new infections annually
are contracted from people who are not yet diagnosed. In an effort to reduce
such transmissions, governments across Europe are working to provide
increased access to HIV testing and early treatment.
"Early diagnosis of HIV provides a significant advantage to patients,"
stated John Sperzel, President and CEO of Chembio. "It's been
well-documented that people who are diagnosed early and who receive early
treatment can expect nearly the same life expectancy as those who are HIV
negative. With Chembio's DPP(R) HIV 1/2 Assay, healthcare professionals in
the member states of the European Union will have an exceptionally
sensitive, specific and rapid diagnostic to support widespread testing and
early treatment," added Sperzel.
Chembio's DPP(R) HIV 1/2 Assay detects HIV antibodies in oral fluid or blood
and uses the Company's patented Dual Path Platform (DPP(R) ) technology,
which offers excellent sensitivity and specificity. The product's unique
SampleTainer(R) specimen collection bottle is a safe, closed system for
collecting potentially infectious samples. The DPP(R) HIV 1/2 Assay is one
of only two FDA-approved, CLIA-waived oral fluid HIV 1/2 rapid tests
available in the U.S. The Company expects to launch sales of the product in
the European Union in the fourth quarter of 2015.

Posted-In: News FDA Press Releases


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