Chembio Announces Plans to Seek EUA Approval from FDA for Revised DPP COVID-19 IgM/IgG System and New DPP COVID-19 Antigen Sy...
July 06 2020 - 4:11PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
global point-of-care diagnostic company focused on infectious
diseases, today announced its plans to submit applications to the
U.S. Food and Drug Administration (FDA) for Emergency Use
Authorization (EUA) for a revised version of the DPP COVID-19
IgM/IgG System, a COVID-19 point-of-care serology system, and the
DPP COVID-19 Antigen System, a new COVID-19 point-of-care antigen
system.
Revised DPP COVID-19 IgM/IgG System
The DPP COVID-19 IgM/IgG System consists of Chembio’s serology
test for COVID-19 and a DPP Micro Reader analyzer. On April 15,
2020, the DPP COVID-19 IgM/IgG System was granted an EUA.
Subsequently, the FDA announced performance review based in part on
a National Institutes of Health/National Cancer Institute (NCI)
process for the evaluation of COVID‑19 serology tests. The NCI
report acknowledges that this process, which evaluates COVID-19
serology test sensitivity and specificity using a panel of
pre-selected samples, may not be indicative of either performance
in the real-world or performance of finger stick blood as used in
the Chembio system.
On June 16, 2020, the FDA revoked the EUA for the DPP COVID-19
IgM/IgG System. As a result, Chembio is revising its system with
the objective of meeting the FDA’s new criteria, including the use
of the NCI process. The versatility of Chembio’s proprietary DPP
platform was critical to Chembio’s ability to initially develop the
DPP COVID-19 IgM/IgG System expeditiously, which enabled the system
to become one of the first COVID-19 antibody tests to receive an
EUA. The flexibility of the DPP platform will facilitate Chembio’s
objective of revising the system to meet the new FDA performance
criteria, and Chembio expects, based on its development efforts to
date, to apply for an EUA for the revised system during the third
quarter of 2020.
“We believe recent positive feedback from a number of customers
confirms that our rapid DPP COVID-19 IgM/IgG System can add
tremendous value in quickly evaluating patient COVID-19 IgM and IgG
antibody values in a variety of settings. We remain confident that
the unique features and benefits of our test platform will make it
one of the preferred solutions for antibody testing worldwide,”
stated Rick Eberly, Chembio’s President and Chief Executive
Officer. “In modifying our serology system, we are seeking to
respond to the FDA’s new performance criteria, as well as the
rapidly evolving scientific and clinical understanding of the virus
that led to the adoption of those criteria.”
Chembio continues to offer the DPP COVID-19 IgM/IgG System
outside the United States.
DPP COVID-19 Antigen System
After having recently obtained positive results from feasibility
work, Chembio is pursuing development of a point-of-care DPP
COVID-19 Antigen System. The DPP COVID-19 Antigen System is
expected to consist of a DPP COVID-19 Antigen Assay and a DPP Micro
Reader analyzer and to use a respiratory specimen, such as a nasal
or nasopharyngeal swab, to detect COVID-19 antigens. The new system
will be developed using the DPP platform, with the objective of
offering COVID-19 detection for diagnosis at the point of care, to
improve clinical outcomes.
“We intend to bring an antigen system to market to help with the
rapid and direct detection of the COVID-19 virus,” stated Mr.
Eberly. “As with other DPP-based systems, we expect it to run in
approximately 15 minutes without requiring the significant up-front
investment and infrastructure needed for molecular detection
systems. We believe a simpler, point-of-care design based on our
DPP technology will be able to help identify infection rates closer
to real time, where and when needed.”
In a separate press release issued today entitled “Chembio
Diagnostics Awarded BARDA Grant for Development of DPP COVID-19
Point-of-Care Antigen System,” Chembio announced it had been
awarded a contract from the Biomedical Advanced Research and
Development Authority, known as BARDA, intended to assist Chembio
in developing its COVID-19 point-of-care antigen system and in
submitting an EUA for the system.
About Chembio Diagnostics
Chembio 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 the
development of, and obtaining an EUA for, a revised COVID-19
serology system and a COVID-19 point-of-care 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 either or both of the proposed COVID-19 systems;
Chembio may be unable to anticipate or respond to FDA regulatory
requirements, or changes in those requirements, with respect to one
or both of the proposed COVID-19 systems, or otherwise may be
unable to obtain or maintain an EUA, or other necessary regulatory
approvals, for either or both of such COVID-19 systems, including
approvals for use of the COVID-19 antigen system as a point-of-care
solution; potential customers may not adopt antibody or
point-of-care antigen 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 or 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 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
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