Chembio Diagnostics Submits FDA De Novo/510(k) Request for DPP SARS-CoV-2 Antigen Test System
December 06 2021 - 8:00AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced that it has submitted a De Novo/510(k) Request to
the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2
Antigen test system.
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 support
development of a COVID-19 point-of-care antigen test system using
Chembio’s proprietary Dual Path Platform (DPP) technology. BARDA
support included funding for the completion of clinical studies and
preparation of a De Novo/510(k) submission for the rapid DPP
SARS-CoV-2 Antigen test system.
The DPP SARS-CoV-2 Antigen test system is designed
to detect SARS-CoV-2 antigens in only 20 minutes, using a minimally
invasive nasal swab and read with a DPP Micro Reader or DPP Micro
Reader 2 optical analyzer.
“The De Novo/510(k) Request for the DPP
SARS-CoV-2 Antigen test system reflects our long-term strategy and
commitment to deliver rapid, decentralized COVID testing solutions
and broaden our portfolio of products in other disease categories
that require rapid results for the U.S. market,” said Richard
Eberly, Chembio’s President and Chief Executive Officer. “We would
like to thank BARDA for their collaborative efforts in the
development of both our COVID-19 tests and the respective
regulatory submissions. We are hopeful for a straightforward review
process with the FDA in order to offer healthcare providers
additional testing solutions to support the evolving needs of the
pandemic.”
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
75A50121P00012.
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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