Chembio Diagnostics Announces Extension of Delivery Schedule for Bio Manguinhos Purchase Order of DPP SARS-COV-2 Antigen Tests
November 15 2021 - 8:00AM
Chembio Diagnostics, Inc. (“Chembio”) (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced that the delivery schedule for shipments of DPP
SARS-COV-2 Antigen Tests under its July 2021 purchase order from
Bio Manguinhos has been extended into March 2021. As the result of
a portion of the shipments now being deliverable after year end,
Chembio believes it now has the opportunity to fulfill all of the
$28.3 million order. Chembio’s delivery of tests covered by the
purchase order, however, continues to be negatively affected by
limitations of Chembio’s supply chain, staffing, and liquidity, and
other matters outside Chembio’s control.
“Bio-Manguinhos is a valued long-time customer,
and we appreciate their collaboration as we strive to meet their
needs during the COVID-19 pandemic,“ said Richard Eberly, Chembio’s
President and Chief Executive Officer. “Our team continues to
maximize the use of our resources to efficiently increase
production capacity. We are focused on making continued
improvements to scale the business for future growth.”
The DPP SARS-CoV-2 Antigen test is designed to
detect the SARS-CoV-2 antigen, which indicates an active COVID-19
infection, in only 20 minutes using a minimally invasive nasal
swab.
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 first
paragraph with respect to Chembio’s belief and current expectations
with respect to its fulfillment of the purchase order from
Bio-Manguinhos 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:
the ability of Chembio to generate revenue from the July Purchase
Orders or other product orders will depend on 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 additional, regulatory approvals, particularly for its
proposed 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 June 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.
Investor Relations
ContactPhilip TaylorGilmartin Group(415)
937-5406investor@chembio.com
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