Chembio’s DPP® HIV-Syphilis Assay Receives CE Mark for Simultaneous Point-of-Care Detection of HIV and Syphilis
January 17 2017 - 8:50AM
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care
(POC) diagnostic tests for infectious diseases, today announced
that it has received a CE mark for its DPP® HIV-Syphilis
combination assay. The Chembio DPP® HIV-Syphilis Assay is now
cleared to be marketed and sold within the member states of the
European Union and the Caribbean region, except for Puerto Rico.
The Chembio DPP® HIV-Syphilis Assay is a
single-use, rapid screening test for the detection of antibodies to
HIV types 1 and 2 and syphilis Treponema pallidum using fingerstick
whole blood, venous whole blood, serum, or plasma. The test
requires a small 10 µl blood sample, is highly sensitive and
specific, provides results in as little as 15 minutes, has a
built-in procedural control, can be stored at room temperature, and
has up to a 24-month shelf life.
John Sperzel, Chembio's Chief Executive Officer,
commented, "We are pleased to receive a CE mark for our
DPP® HIV-Syphilis Assay, which allows us to market and sell
the test in Europe and the Caribbean region, except for Puerto
Rico. We believe the DPP® HIV-Syphilis Assay can play a role
in the global initiative to reduce transmission of HIV and syphilis
to unborn children, as well as to screen certain populations to
address growing HIV and syphilis co-infection rates."
Co-infection rates of HIV and syphilis are on
the rise and, according to the Centers for Disease Control and
Prevention, there is an estimated two-to-five-fold increased risk
of contracting HIV if exposed to that infection when syphilis is
present. Further, an estimated two million pregnancies
annually are affected by mother-to-child-transmission of HIV and/or
syphilis, resulting in high rates of stillbirth, spontaneous
abortion, low birth weight and perinatal death. Congenital syphilis
is a preventable disease, which could be significantly reduced
through effective prenatal screening, and treatment of infected
pregnant women.
"We intend to leverage our patented
DPP® platform to deliver diagnostic tests that are most needed
in each corner of the world. In the U.S., our goal is to bring
our DPP® HIV-Syphilis Assay to market as quickly as possible,
as there currently are no other such combination tests available in
the U.S. market. We plan to complete a U.S. clinical trial for our
DPP® HIV-Syphilis Assay and file for U.S. regulatory approval
in early 2017. In addition to our receipt of a CE mark for
the DPP® HIV-Syphilis Assay, we have previous regulatory
approvals in Mexico and Brazil, and we are working to obtain
approvals in certain Southeast Asia countries, following our recent
acquisition of Malaysia-based RVR Diagnostics,” added Sperzel.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops,
manufactures, licenses and markets proprietary rapid diagnostic
tests in the growing $8.0 billion point-of-care testing
market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV
1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these
Chembio brand names, in the U.S. and internationally both directly
and through third-party distributors. The Company's SURE
CHECK® HIV 1/2 Assay previously has been exclusively sold in the
U.S. as Clearview® Complete HIV 1/2 Assay.
Chembio has developed a patented point-of-care
(POC) 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.
Headquartered in Medford, NY, 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 13485. Chembio Diagnostic Systems Inc. is a wholly-owned
subsidiary of Chembio Diagnostics, Inc. For more information,
please visit: 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.
Contacts:
Chembio Diagnostics
Susan Norcott
(631) 924-1135, ext. 125
snorcott@chembio.com
Vida Strategic Partners (investor relations)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Apr 2023 to Apr 2024