Chembio Diagnostics Announces Completion of U.S. Clinical Trial Evaluating DPP® HIV-Syphilis System
December 21 2017 - 8:50AM
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care
(POC) diagnostic tests for infectious diseases, today announced
completion of the U.S. clinical trial evaluating its
DPP® HIV-Syphilis System. The Company plans to file a
Pre-Market Approval (PMA) submission with the Food and Drug
Administration (FDA) during the first quarter of 2018 to support
commercialization of the first POC HIV-Syphilis assay in the
U.S.
The Chembio DPP® HIV-Syphilis System, which
includes the DPP® HIV-Syphilis Assay and DPP® Micro Reader, is a
single-use, rapid screening test for the detection of antibodies to
HIV types 1 and 2 and syphilis Treponema pallidum (the
causative agent for syphilis) using fingerstick whole blood,
venous whole blood, or plasma. The test is performed using a small
10 µl fingerstick 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.
The U.S. clinical trial designed to evaluate the
accuracy of the DPP® HIV-Syphilis System resulted with sensitivity
and specificity that met the study objectives of the clinical
protocol. The results of the clinical trial will be filed with the
PMA submission for review by the FDA.
John Sperzel, Chembio's Chief Executive Officer,
commented, "Chembio is aggressively pursuing a three-pronged growth
strategy, which includes the strengthening of our sexually
transmitted disease business, continued development of our fever
disease portfolio, and additional pursuit and development of new
and existing technology collaborations. Commercialization of the
DPP® HIV-Syphilis Assay in the U.S. is a key element of our
strategy, and completion of the U.S. clinical trial brings this
novel product closer to the market. During the first quarter
of 2018, we plan to file a PMA submission with the FDA, and we look
forward to launching the DPP® HIV-Syphilis System in the U.S.
market following FDA approval."
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.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops,
manufactures, licenses and markets rapid diagnostic tests in the
growing $8.0 billion POC testing market. The Company markets its
products directly and through third-party distributors under
the brand names: DPP®, STAT-PAK®, SURE CHECK®, and
STAT-VIEW®.
Chembio has developed and patented
the DPP® technology platform, which offers significant
advantages over traditional POC lateral-flow technologies and
provides the Company with a significant pipeline of business
opportunities in the area of sexually transmitted disease, tropical
and fever disease, and technology collaborations.
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. Each of Chembio Diagnostic Systems Inc. and
Chembio Diagnostics Malaysia Sdn Bhd 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.
Contact:
Vida Strategic Partners (investor relations)Stephanie C.
Diaz(415) 675-7401sdiaz@vidasp.com
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