Chembio Diagnostics Receives $4 Million HIV Test Purchase Order Supported by The Global Fund
July 22 2021 - 12:49PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
announced its receipt today of a $4 million purchase order from the
Partnership for Supply Chain Management (PFSCM), supported by The
Global Fund, for the purchase of Chembio’s
HIV 1/2 STAT-PAK Assay for shipment to Ethiopia into
early 2022. Chembio’s delivery of the full number of tests covered
by the purchase order may be affected by limitations of Chembio’s
supply chain, staffing, and liquidity, and other matters outside
Chembio’s control.
The HIV 1/2 STAT-PAK Assay is a World Health
Organization (WHO) prequalified, rapid point-of-care assay for the
detection of HIV-1 and HIV-2 antibodies in fingerstick whole blood,
venous whole blood, serum, or plasma. With 99.7% sensitivity and
99.9% specificity, the HIV 1/2 STAT-PAK Assay is the only
HIV test that exceeds WHO performance thresholds according to an
independent, multi-site study published in the Journal of the
International AIDS Society in 2017. Its innovative design can be
performed in three simple steps with minimal training, requires
only 5 microliters of blood, and includes a built-in biological
control. A version of the HIV 1/2 STAT-PAK Assay for the
U.S. market has received premarket approval (PMA) and a Clinical
Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food
and Drug Administration.
“We are proud to continue our support of The Global Fund’s
pursuit of UNAIDS’s ‘90-90-90’ targets,” said Richard L. Eberly,
Chembio’s President and Chief Executive Officer. “We look forward
to working closely with PFSCM to continue the supply of our
high-quality HIV tests to help the people of Ethiopia know their
HIV status and obtain treatment.”
Chembio was first awarded the front-line testing algorithm
position in Ethiopia in 2018 to screen for HIV. With this latest
purchase order, Chembio is continuing that important role, now
under the contractual auspices of The Global Fund, and expanding
its longstanding relationship with PFSCM, which leverages its
planning and logistics resources for clients, governments, and
nongovernmental organizations (NGOs) in over 85 countries.
Testing for HIV across Africa and Asia fell by 41% during the
period from April to September 2020 compared to the same period in
2019, according to an April 2021 report by The Global Fund on the
disruptive impact of the COVID-19 pandemic, despite The Global
Fund’s actions to continue essential HIV services and protect
healthcare workers. The Joint United Nations Programme on HIV/AIDS
(UNAIDS) has identified “90-90-90” targets under which 90% of
HIV-positive people will know their status, 90% of HIV-positive
people who know their status will be on HIV treatment, and 90% of
people on HIV treatment will have achieved viral suppression and
have undetectable levels of HIV in their bodies.
About Chembio DiagnosticsChembio is a leading
point-of-care diagnostics company focused on detecting and
diagnosing infectious diseases, including COVID-19, sexually
transmitted, respiratory and insect vector diseases. 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
Certain statements contained in the first and third paragraphs
above are not historical facts and may be forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include statements
regarding the intent, belief or current expectations with respect
to manufacturing, distribution, and sale of the HIV 1/2 STAT-PAK
Assay pursuant to the purchase order from PFSCM. 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, Ethiopia, and globally: constraints on Chembio’s
supply chain, staffing, and other resources that could inhibit
Chembio’s ability to deliver the number of tests contemplated by
the purchase order from PFSCM; the need for Chembio to obtain
sufficient working capital to fund the procurement of raw
materials, the employment and recruitment of personnel, and other
costs associated with manufacturing tests, as well as Chembio’s
ongoing operational infrastructure; the risks of doing business
with foreign governmental entities, including geopolitical,
international, and other challenges; the ability of Chembio to
maintain existing, and timely obtain additional, regulatory
approvals for its HIV tests, which approvals are subject to
processes that can change recurringly without notice; and, the
highly competitive market for testing solutions for HIV, which
includes a number of competing companies with strong relationships
with current and potential customers, including governmental
authorities, and with significantly greater financial and other
resources that are available to 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 periodic 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, 2020 and
its subsequent Quarterly Reports on Form 10-Q and Current Reports
on Form 8-K, 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 and STAT-PAK are Chembio’s registered trademarks. For
convenience, these trademarks appear 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 trademarks.
Contact:Philip TaylorGilmartin Group(415)
937-5406investor@chembio.com
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