Chembio Submits EUA Application for New DPP SARS-CoV-2 IgM/IgG Test System
September 08 2020 - 6:01PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced its initiation of the notification process and
submission of an application for Emergency Use Authorization (EUA)
to the U.S. Food and Drug Administration (FDA) for its new rapid
antibody test system, DPP SARS-CoV-2 IgM/IgG.
“We are pleased to have accomplished all of our
objectives in the development and validation of the new DPP
SARS-CoV-2 IgM/IgG test system,” stated Richard Eberly, Chembio’s
President and Chief Executive Officer. “Submission of the EUA
application for this test system has been the top priority for our
organization because we understand there is a large need in the
market for additional rapid tests – especially ones that offer the
ability to decentralize testing locations. We are excited to offer
a solution to patients and clinicians across the healthcare system
that addresses these needs.”
The DPP SARS-CoV-2 IgM/IgG test system detects
antibodies to the Spike Receptor Binding Domain in the blood that
the body produces in response to a COVID-19 infection. Objective
results can be obtained within 15 minutes using finger stick,
venous whole blood, plasma, or serum samples, and Chembio’s
cost-effective, highly portable, battery-powered Micro Reader 1 or
Micro Reader 2 analyzers that are produced by Chembio Germany. The
DPP platform’s ability to provide objective, numerical results can
aid clinicians in avoiding the human interpretation errors
associated with visual readings of traditional lateral flow
tests.
IgM and IgG antibody test results assist clinicians
in determining current or past exposure to the COVID-19 virus. The
results and data from the test can contribute to improved clinical
outcomes through the management of individual patients, as a
population surveillance tool, and to potentially evaluate immune
responses to anticipated vaccine administration.
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. The company’s
proprietary DPP technology platform, which uses a small drop of
blood from the fingertip or alternative sample types, provides
high-quality, cost-effective results in approximately 15 minutes.
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.
Forward-Looking Statements
Statements 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
obtaining an EUA for a COVID-19 antibody 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 antibody system; Chembio may be
unable to anticipate or respond to changes in FDA regulatory
requirements with respect to its proposed COVID-19 antibody 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 may not adopt antibody 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 antibody 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
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Sep 2023 to Sep 2024