Chembio Announces EUA Submission for DPP Respiratory Antigen Panel
September 22 2021 - 8:00AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced the submission of an Emergency Use Authorization
(EUA) application to the Food and Drug Administration (FDA) for the
company’s DPP Respiratory Antigen Panel test system.
The DPP Respiratory Antigen Panel test system is
designed to provide simultaneous, discrete, and differential
detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from
a single patient sample using a simple nasal swab. The test system
is expected to provide results in approximately 20 minutes and be
read on Chembio’s DPP Micro Reader analyzer. The system is intended
to enable appropriate clinical management of patients with
suspected respiratory infections and to assist in the containment
of COVID-19 cases during the flu season.
“Our DPP Respiratory Antigen Panel test system
represents an additional differentiated offering among our COVID
testing portfolio that can help clinicians at decentralized testing
locations gain essential information about a patient’s infection
status in only 20 minutes. COVID-19 infection rates are rising as
we approach the flu season, and it is critical for clinicians to be
able, at the point of care, to quickly triage respiratory infection
patients with symptoms common to both COVID and flu infections and
then administer the proper treatment regimen,” said Richard L.
Eberly, Chembio’s President and Chief Executive Officer. “We
believe this approach, as recommended by the U.S. Centers for
Disease Control and Prevention, can save both time and resources.
We are thankful for BARDA’s support and guidance throughout the
development and evaluation of this test system.”
The DPP Respiratory Antigen Panel test system was
developed with funds and support as part of a $12.7 million
contract awarded by 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 also supports preparation of a
submission to the FDA in pursuit of 510(k) clearance for the DPP
SARS-CoV-2 Antigen test system.
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 such as respiratory 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 ProjectThis project has been funded
in whole or in part with 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
StatementsCertain statements contained in the second and
third paragraphs above are not historical facts and may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include statements regarding the intent, belief or
current expectations with respect to the regulatory approval,
distribution and sale of Chembio’s DPP Respiratory Antigen Panel
test system, and the availability, timing, functionality and
regulatory approval of the test systems. Such statements, which are
expectations 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
forward-looking statements due to a number of important factors,
and will be dependent upon a variety of factors, including, but not
limited to, the following, any of which could be exacerbated even
further by the continuing COVID-19 outbreak in the United States
and globally: 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
otherwise may be unable to obtain or maintain an EUA or other
necessary regulatory approvals; Chembio’s development and
commercialization efforts may not result in it successfully and
timely developing and commercializing the DPP Respiratory Antigen
Panel point-of-care test system; potential customers may not
adopt point-of-care antigen systems to the extent expected by
Chembio; Chembio business plans depend significantly upon, but
Chembio has limited experience with, COVID-19 diagnostic tests; 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 periodic public filings with the
U.S. Securities and Exchange Commission, including its Quarterly
Reports on Form 10-Q for the quarterly periods ended March 31, 2021
and June 30, 2021, and its Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 19, 2021,
particularly under the heading “Risk Factors” or similar
headings.
DPP is Chembio’s registered trademark, and the Chembio logo is
Chembio’s trademark. For convenience, these trademarks appear in
this release without ® or ™ 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 Taylor Gilmartin
Group415-937-5406investor@chembio.com
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