Chembio Diagnostics Receives SAHPRA Approval for DPP SARS-CoV-2 Antigen Test
November 29 2021 - 8:00AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced receipt on November 26, 2021, of South Africa
Health Products Regulatory Authority (SAHPRA) approval for the DPP
SARS-CoV-2 Antigen test, authorizing marketing and distribution of
the test for use at the point-of-care by professional healthcare
providers.
“We are pleased that independent evaluation of
the DPP SARS-CoV-2 Antigen test again demonstrated strong
sensitivity and specificity performance. This is another validation
of the DPP technology that expands the regulatory approvals
received by our COVID testing portfolio,” said Richard Eberly,
Chembio’s President and Chief Executive Officer. “South Africa
represents a large testing market opportunity. We are excited to
provide our distributor, Patient Focus Africa (PFA), with another
testing solution in addition to our DPP SARS-CoV-2 IgM/IgG Antibody
test, to help manage the evolving needs of the pandemic in South
Africa.”
The DPP SARS-CoV-2 Antigen test has been
designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP
SARS-CoV-2 Antigen test uses a minimally invasive nasal swab and is
designed to be read visually or with a DPP Micro Reader 2 optical
analyzer. Both the DPP SARS-CoV-2 Antigen test and the IgM/IgG
Antibody test are authorized for import and distribution in South
Africa by Chembio’s distributor, Patient Focus Africa, pursuant to
licenses issued by SAHPRA. PFA is a World Health Organization
accredited company for near patient testing, wellness, and
professional point of care testing. PFA is partially owned by
Discovery Health, the largest private healthcare Insurance provider
in South Africa, and services both the public and private
healthcare markets in the country.
“We have 22 years’ experience of using quality
point of care and rapid tests in the Southern African market. We
have conducted millions of tests over this period of time. Let me
state unequivocally: the Chembio DPP platform/test is in a league
of its own. The quality control built into the strip, the ease of
collecting quality samples, and the receipt of results that you can
trust time after time – this is truly lifesaving,” said Jacques du
Toit, Founder and Manager Director of Patient Focus Africa. “These
sentiments are expressed and shared by our customers. Thank you
Chembio for adding life to days; days to life!”
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.
Forward-Looking
StatementsCertain statements contained in the second
paragraph with respect to Chembio’s belief and current expectations
with respect to the potential distribution of the DPP SARS-CoV-2
Antigen test in South Africa are not historical facts and may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements, which
are expectations only, 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, the following, any of which could be exacerbated even
further by the continuing COVID-19 outbreak in the United
States and globally: actions taken by PFA, the sole
distributor of DPP SARS-CoV-2 Antigen tests in South Africa, will
determine the extent, if any, to which Chembio is able to generate
revenue from the distribution of the tests in South Africa and
those actions are outside Chembio’s control; the availability and
cost of human, material and other resources required to build and
deliver the tests, which factors are largely outside Chembio’s
control; the ability of Chembio to maintain existing, and timely
obtain any required additional, regulatory SAHPRA approvals for
COVID-19 diagnostic tests, which approvals are subject to processes
that can change recurringly without notice; Chembio’s dependence
upon, and limited experience with, COVID-19 diagnostic tests; and
the risks of doing business with foreign governmental entities,
including geopolitical, international and other challenges as well
as potential material adverse effects of tariffs and other changes
in U.S. trade policy. 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
periodic public filings with the U.S. Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2021, particularly under
the heading “Risk Factors.”
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 trademarks. All
other trademarks appearing in this release are the property of
their respective owners.
Contact:Philip Taylor Gilmartin
Group415-937-5406investor@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