Chembio Diagnostics Awarded BARDA Contract for Development of DPP COVID-19 Point-of-Care Antigen System
July 06 2020 - 4:10PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced it has been awarded a contract from the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response at
the U.S. Department of Health and Human Services. The contract is
intended to assist Chembio in developing a COVID-19 point-of-care
antigen system using Chembio’s proprietary DPP technology and
requesting a U.S. Food and Drug Administration Emergency Use
Authorization (EUA) for the system. The award totals $628,071 and
is to be distributed in periodic funding over the next several
months.
Chembio will use the funds under contract number 75A50120C00138
to accelerate development of its DPP COVID-19 Antigen System, which
is expected to consist of a DPP COVID-19 Antigen Assay and DPP
Micro Reader and to use a respiratory specimen, such as a nasal or
nasopharyngeal swab, to detect SARS-CoV-2 antigens.
“We are honored to again partner with BARDA and appreciate their
support on a shared mission to expand and decentralize COVID-19
testing,” stated Rick Eberly, Chembio’s President and Chief
Executive Officer. “We believe offering virus detection for
diagnosis at the point of care can improve clinical outcomes and
play a major role in combating the ongoing pandemic.”
About Chembio DiagnosticsChembio
is a leading point-of-care diagnostics company focused on detecting
and diagnosing infectious diseases, including COVID-19, sexually
transmitted disease, and fever and tropical disease. The company’s
proprietary DPP technology platform, which uses a small drop of
blood from the fingertip or alternative sample types, provides
high-quality, cost-effective results in approximately 15 minutes.
Coupled with Chembio’s extensive scientific expertise, its novel
DPP technology offers broad market applications beyond infectious
disease. Chembio’s products are sold globally, directly and through
distributors, to hospitals and clinics, physician offices, clinical
laboratories, public health organizations, government agencies, and
consumers. Learn more at www.chembio.com.
Forward-Looking
StatementsStatements contained in this release 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 Chembio and its management with respect to
the development of, and obtaining an EUA for, a COVID-19
point-of-care antigen system. Such statements reflect management's
current views, are based on certain assumptions, and involve risks
and uncertainties. Actual results, events, or performance may
differ materially from 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 research,
development and commercialization efforts may not result in its
successfully and timely developing and commercializing a COVID-19
point-of-care antigen system; Chembio may be unable to anticipate
or respond to changes in FDA regulatory requirements with respect
to its proposed COVID-19 antigen system, or otherwise may be unable
to obtain or maintain an EUA, or other necessary regulatory
approvals, for its COVID-19 antigen system, including approvals for
use of that system as a point-of-care solution; potential customers
may not adopt point-of-care antigen systems to the extent expected
by Chembio; and Chembio may not be able to compete successfully
with other companies that have developed, or develop in the future,
COVID-19 antigen detection systems, some of which companies have
substantially greater resources than Chembio. Chembio undertakes no
obligation to publicly update forward-looking statements in this
release to reflect events or circumstances that occur after the
date hereof or to reflect any change in Chembio's expectations with
regard to the forward-looking statements or the occurrence of
unanticipated events. Factors that may impact Chembio's success are
more fully disclosed in Chembio's public filings with the U.S.
Securities and Exchange Commission, including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2019 and its
subsequent Quarterly Reports on Form 10-Q, particularly under the
heading “Risk Factors.” Readers should interpret many of the risks
identified in these reports as being heightened as a result of the
ongoing and numerous adverse impacts of the COVID-19 pandemic.
DPP is Chembio’s registered trademark. For convenience, this
trademark appears in this release without ® symbols, but that
practice does not mean that Chembio will not assert, to the fullest
extent under applicable law, its rights to the trademark.
Contact: Philip TaylorGilmartin
Group(415) 937-5406investor@chembio.com
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