Chembio Diagnostics Awarded $12.7 Million by BARDA for Development of Rapid DPP Respiratory Antigen Panel and 510(k) Submissi...
December 02 2020 - 1:22PM
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), which is part
of the U.S. Department of Health and Human Services’ Office of the
Assistant Secretary for Preparedness and Response. The contract
will support the development and pursuit of U.S. Food and Drug
Administration (FDA) Emergency Use Authorization (EUA) for a rapid,
multiplex DPP Respiratory Antigen Panel point-of-care test system
using Chembio’s proprietary DPP technology for the upcoming flu
season.
The contract also supports preparation of a submission in
pursuit of FDA 510(k) clearance for the rapid DPP SARS-CoV-2
Antigen test system that was recently submitted to the FDA for an
EUA. The award totals $12,691,726.
The DPP Respiratory Antigen Panel test system is
intended to provide simultaneous, discrete, and differential
detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from
a single patient respiratory specimen, such as a nasal or
nasopharyngeal swab. It is expected to provide results in
approximately 20 minutes and be run on Chembio’s DPP Micro Reader
analyzer. The system is intended to enable appropriate clinical
management of patients with suspected respiratory infections and
assist in the containment of COVID-19 cases during the flu
season.
The U.S. Centers for Disease Control and Prevention
has recognized that contemporaneous testing for the three viruses
will provide public health officials with information to help limit
the spread of the viruses while conserving scarce resources.
A second portion of the contract will support the verification,
process validation, and production of clinical validation data to
be included in a submission to the FDA for 510(k) clearance and
CLIA-waiver for the DPP SARS-CoV-2 Antigen test system. This system
consists of a DPP SARS-CoV-2 Antigen test cartridge and a DPP Micro
Reader analyzer and is designed to use a minimally invasive nasal
swab to detect SARS-CoV-2 viral antigens in only 20 minutes. The
system was developed by Chembio and submitted to the FDA for an EUA
on October 15, 2020, with support from BARDA under contract number
75A50120C00138.
“We are honored to again partner with BARDA and
appreciate their support as we endeavor on the shared mission to
expand and decentralize COVID-19 testing,” stated Richard Eberly,
Chembio’s President and Chief Executive Officer. “The DPP
technology is highly versatile, and these new product and
regulatory objectives illustrate our commitment to offering virus
detection for diagnosis at the point-of-care. We believe rapid,
point-of-care tests can improve clinical outcomes and play a major
role in combating this ongoing pandemic, especially during the
upcoming flu season.”
About the DPP Rapid Test
PlatformChembio’s proprietary DPP technology platform
provides high-quality, rapid diagnostic results in 15 to 20 minutes
using a small drop of blood from the fingertip or alternative
samples. Through advanced multiplexing, the DPP platform can detect
up to eight, distinct test results from a single patient sample,
delivering greater clinical value than other rapid tests. For
certain applications, Chembio’s easy-to-use, highly portable,
battery-operated DPP Micro Reader optical analyzer then reports
accurate results in approximately 15 seconds, making it well-suited
for decentralized testing where real-time results enable patients
to be clinically assessed while they are still on-site. Objective
results produced by the DPP Micro Reader reduce the possibility of
the types of human error that can be experienced in the visual
interpretations required by many rapid tests.
Chembio’s portfolio of DPP-based point-of-care
tests with FDA regulatory approvals include the DPP HIV-Syphilis
System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA
waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System
(EUA). Additionally, DPP-based tests have received regulatory
approvals from the World Health Organization, CE-Mark, Agência
Nacional de Vigilância Sanitária (ANVISA), and other global
organizations, where they aid in the detection and diagnosis of
several other critical diseases and conditions.
All DPP tests are developed and manufactured in the
United States and are the subject of a range of domestic and global
patents and patents pending.
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. 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.
About the ProjectChembio will use
the federal funds from the Department of Health and Human Services;
Office of the Assistant Secretary for Preparedness and Response;
Biomedical Advanced Research and Development Authority, under
Contract No. 75A50121P00012.
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 the DPP Respiratory Antigen Panel point-of-care
test system or the DPP SARS-CoV-2 Antigen test system; Chembio may
be unable to anticipate or respond to changes in FDA regulatory
requirements with respect to its proposed DPP Respiratory Antigen
Panel point-of-care test system or DPP SARS-CoV-2 Antigen test
system, or otherwise may be unable to obtain or maintain an EUAor
other necessary regulatory approvals; 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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