Chembio Diagnostics Submits EUA Application for DPP SARS-CoV-2 Antigen Test System
October 15 2020 - 5:55PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced the submission of an application for Emergency Use
Authorization (EUA) to the U.S. Food and Drug Administration (FDA)
for the DPP SARS-CoV-2 Antigen test system, which has been designed
to detect SARS-CoV-2 antigens in only 20 minutes. The DPP
SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen
test cartridge, a DPP Micro Reader optical analyzer and a
minimally-invasive nasal swab.
“The antigen test system EUA submission is another
example of the scientific expertise of our team and the flexibility
of our DPP technology,” said Richard Eberly, Chembio’s President
and Chief Executive Officer. “We are committed to leveraging this
technology to offer a comprehensive COVID-19 testing portfolio. The
DPP platform is ideally suited as a cost-effective system for rapid
testing at the point of care and can help expand patient access to
testing. Rapid antigen testing has proven to be one of the most
effective methods for population screening and diagnosis available
today. Offering both antibody and antigen testing using the same
Micro Reader will enable clinicians to both diagnose and monitor
COVID-19 infection status with Chembio products. Thank you to our
team and to BARDA for their support throughout the development of
the antigen system. We look forward to working with the FDA to
achieve EUAs as soon as possible for the DPP SARS-CoV-2 Antigen
test system and our previously submitted antibody test system.”
As defined by the U.S. Centers for Disease Control
and Prevention, part of the U.S. Department of Health and Human
Services (HHS), antigen tests are immunoassays that detect the
presence of a specific viral antigen, which imply a current viral
infection. Rapid antigen tests are commonly used in the diagnosis
of respiratory pathogens, including influenza viruses and
respiratory syncytial virus.
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,
which can deliver 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’s
development of a COVID-19 point-of-care antigen system using DPP
technology and its request for an EUA for the system 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, Division of Research Innovation and Ventures
under Contract No. 75A50120C00138.
Forward-Looking
StatementsStatements contained in the second paragraph of
this release that are not historical facts may be forward-looking
statements within the meaning of the Securities Act of 1933.
Forward-looking statements include statements regarding the intent,
belief or current expectations of Chembio and its management with
respect to the marketing and sale of the DPP SARS-CoV-2 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 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;
potential customers in the United States may not adopt the DPP
SARS-CoV-2 Antigen system to the extent expected by Chembio;
Chembio may not succeed in obtaining a CLIA Waiver with respect to
the DPP SARS-CoV-2 Antigen system; 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 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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