Chembio Diagnostics Submits EUA Application for New DPP SARS-CoV-2 Antigen Test
November 16 2021 - 4:05PM
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 U.S. Food and Drug Administration (FDA)
for the new DPP SARS-CoV-2 Antigen test.
Previously, Chembio received an award from the
Biomedical Advanced Research and Development Authority (BARDA),
part of the U.S. Department of Health and Human Services’ Office of
the Assistant Secretary for Preparedness and Response, to assist in
developing a COVID-19 point-of-care antigen test system using
Chembio’s proprietary DPP technology and requesting FDA EUA for the
test system. The DPP SARS-CoV-2 Antigen test system has been
designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP
SARS-CoV-2 Antigen test system is now designed to use a minimally
invasive nasal swab and be read visually or with a DPP Micro Reader
or DPP Micro Reader 2 optical analyzer.
“We are steadfast in our commitment to
leveraging our proprietary DPP technology to address COVID-19
testing needs, while offering a broad portfolio of testing
solutions for a variety of healthcare customers. Rapid
point-of-care testing has proved to be one of the best tools for
mitigating the spread of the virus as rapid results enable
healthcare workers to initiate on-site patient management,” said
Richard Eberly, Chembio’s President and Chief Executive Officer.
“We are pleased to have completed the submission which we view as a
testament to our team’s dedication and technical expertise. Again,
we would like to extend our gratitude to BARDA for their continued
guidance and support throughout this process. We look forward to
working closely with BARDA and the FDA to bring patients and health
care workers the benefits of 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. 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, 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 diagnostics company
focused on developing and commercializing point-of-care tests used
for the rapid detection and diagnosis of infectious diseases,
including sexually transmitted disease, insect vector and tropical
disease, COVID-19 and other viral and bacterial infections,
enabling expedited treatment. 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 number
75A50120C00138.
Contact: Philip Taylor Gilmartin
Group415-937-5406investor@chembio.com
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