Chembio Diagnostics Receives FDA Emergency Use Authorization for the First Rapid Zika IgM Test
September 28 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 U.S.
Food and Drug Administration (FDA) Emergency Use Authorization
(EUA) for its DPP® Zika System.
The DPP® Zika System, which provides
results in 15-20 minutes from only 10µL of blood, is the first
rapid Zika test to receive an FDA EUA for use in high and moderate
complexity CLIA certified laboratories. The DPP® Zika System
includes the DPP® Zika IgM Assay and DPP® Micro Reader, which is
portable, hand-held, easy to use, and can reduce the risk of human
error during test interpretation.
The test is authorized for the presumptive
detection of Zika virus IgM antibodies in fingerstick whole blood,
EDTA venous whole blood, EDTA plasma (each collected alongside a
patient-matched serum specimen) or serum (plain or separation gel)
specimens collected from individuals meeting CDC Zika virus
clinical and/or epidemiological criteria, from 8 days of on-set and
up to 12 weeks.
The DPP® Zika System has been
authorized by FDA under an EUA for use in authorized laboratories
in the United States that are certified under the Clinical
Laboratory Improvement Amendment (CLIA), to perform high or
moderate complexity tests, or by similarly qualified non-U.S.
laboratories. The DPP® Zika System utilizes the
patented technology platform used in the Company's FDA
approved and CLIA waived DPP® HIV 1/2 Assay. The
DPP® Zika System has not been FDA cleared or approved and has been
authorized only for the diagnosis of Zika virus infection and not
for any other viruses or pathogens. The DPP® Zika System is only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of the emergency use of in vitro
diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C.
§ 360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
Sharon Klugewicz, acting Chief Executive
Officer, commented, “We are delighted to receive FDA Emergency
Use Authorization for our DPP® Zika System and we
appreciate the close interaction with the FDA throughout the EUA
process. We believe the deployment of a rapid test for the
presumptive detection of human IgM antibodies to Zika virus
will be a critical tool in dealing with the ongoing spread of Zika
virus, and we plan to make the DPP® Zika
System immediately available in the U.S., Puerto Rico, and the
U.S. Virgin Islands.”
This project has been funded in part with
federal funds from the U.S. Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority
(BARDA). Chembio has been awarded a contract for $5.9 million
to develop the product and obtain FDA EUA authorization and FDA
510(k) clearance with the potential of $13.2 million in total
funding from BARDA if all options are exercised, to advance
clinical development of its DPP® Zika System and
its DPP® Zika / Dengue / Chikungunya System.
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® and SURE CHECK®.
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
registered with 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.
Contacts:
Vida Strategic Partners Stephanie C. Diaz (investor relations)
(415) 675-7401 sdiaz@vidasp.com
Tim Brons (media) (415) 675-7402 tbrons@vidasp.com
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