Chembio Diagnostics Receives $28.3 Million Purchase Order from Bio-Manguinhos for DPP SARS-CoV-2 Antigen Tests in Brazil
July 20 2021 - 10:56PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
announced its receipt today of a $28.3 million purchase order from
Bio-Manguinhos for the purchase of Chembio’s DPP SARS-CoV-2 Antigen
tests for delivery during 2021 to support the urgent needs of
Brazil’s Ministry of Health in addressing the COVID-19 pandemic.
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. 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.
Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation
(Fiocruz), is responsible for the development and production of
vaccines, diagnostics, and biopharmaceuticals, primarily to meet
demands of Brazil’s national public health system. Chembio has a
long-standing relationship with Bio-Manguinhos, having supplied
multiple products for point-of-care detection of COVID-19
antibodies, HIV, and other infectious diseases. Bio-Manguinhos
received regulatory approval from Agência Nacional de Vigilância
Sanitária (ANVISA) in March 2021, following ANVISA approval of the
test for Chembio’s Brazilian subsidiary in November 2020.
“We are pleased to significantly expand our customer
relationship with Bio-Manguinhos to address the testing needs
surrounding COVID-19,” said Javan Esfandiari, Chembio’s Executive
VP, Chief Science & Technology Officer. “Enabling providers to
test patients at the point-of-care and determine their infection
status in only 20 minutes can be one of the most effective methods
for controlling the spread of COVID-19 and improving patient
outcomes. We believe the purchase order validates the investments
we made earlier this year in inventory for the DPP SARS-CoV-2
Antigen test and look forward to ramping up production. We are very
proud to provide this test in Brazil and assist in efforts to
manage the global pandemic.”
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
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 DPP SARS-CoV-2
Antigen test pursuant to the purchase order from Bio-Manguinhos.
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, Brazil, 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 Bio-Manguinhos; 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 and
Bio-Manguinhos to maintain existing, and timely obtain additional,
regulatory approvals for its 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 highly competitive and
rapidly developing market for testing solutions for COVID-19, 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 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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