Chembio Diagnostics Announces Agreement for Reszon Diagnostics International to Manufacture Chembio’s HIV 1/2 STAT-PAK Assay at Chembio Diagnostics Malaysia Facility
May 17 2022 - 8:00AM
Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI),
a leading point-of-care diagnostic company focused on
infectious diseases, today announced it has entered into a
manufacturing agreement with Reszon Diagnostics International Sdn.
Bhd. (Reszon) to produce Chembio’s HIV 1/2 STAT-PAK Assay
products in the Chembio Diagnostics Malaysia (CDM) facility. CDM
had previously suspended operations in May 2020.
This new manufacturing arrangement will leverage CDM’s product
and facility qualification by the World Health Organization
Prequalification Program and ISO 13485 certification. The
relationship will also combine Chembio’s manufacturing abilities
with Reszon’s resources and manufacturing strengths in the
diagnostics space. Operations are planned to commence in the third
quarter of 2022 dependent on reaching certain quality, production
and other targets.
“We are excited to be working with Reszon, a leader in Malaysian
diagnostics test kits, to optimize our global manufacturing by
leveraging our Malaysian resources. This represents a major
milestone in our Global Competitiveness Program to improve
profitability,” said Richard Eberly, Chembio’s Chief Executive
Officer and President. “We believe this new relationship will
increase our capacity to supply new markets, bolster our
competitiveness and strengthen our position in rapid point-of-care
testing. We look forward to exploring commercial opportunities in
Malaysia and other high-growth markets.”
“Chembio offers best-in-class technology, and we are confident
we can significantly scale manufacturing of their tests,” said EL
Law, Reszon’s Chief Executive Officer. “We are eager to work with
the entire Chembio team and expand our business in the Malaysian
and international markets. We see this as an excellent opportunity
for both parties to leverage our individual strengths. We feel this
can take us both to the next level of commercial success and look
forward to a long and mutually beneficial relationship.”
About Chembio DiagnosticsChembio is a leading
diagnostics company focused on developing and commercializing
point-of-care tests used to detect and diagnose 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.
About Reszon Diagnostics
InternationalEstablished since 2010, Reszon develops and
manufactures a strong portfolio of innovative in vitro diagnostics
(IVD) rapid tests and ELISA kits for medical professionals,
including clinical diagnostic markets worldwide. Reszon’s IVD rapid
test kits allow medical professionals to diagnose diseases quickly
and accurately for the early detection and prevention of diseases.
The easy to use and portability of its rapid test kits make them
ideal for use in wide range of settings, including remote areas and
countries where sophisticated medical diagnostics are not
available. Reszon has supplied over 20 million tests in South East
Asia making it the largest regional supplier of Covid Self Testing
Kits. Reszon is actively transforming its manufacturing process to
full automation in order to competitively address growing global
needs. Reszon is also committed to providing the best affordable
diagnostics in the self-testing sector.
Forward-Looking StatementsCertain statements
contained in the second 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 the timing and
operational and financial success of Chembio’s agreement with
Reszon. 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, Malaysia and globally:
Chembio’s ability to receive and sell products contemplated by the
agreement could be materially constrained by global events,
including continuing COVID-19 outbreaks and the armed conflict in
Ukraine, leading to transportation delays, logistics disruptions
and supply chain limitations that could materially adversely affect
the ability of Reszon to manufacture products under the agreement;
Chembio and Reszon may encounter regulatory or other delays in
commencing manufacturing under the agreement, many of which may be
outside the control of Chembio; Chembio may be unable to manage and
monitor manufacturing at the CDM facility to ensure product
compliance with applicable requirements of the World Health
Organization and international regulators; potential customers may
not adopt or require products produced under the agreement to the
extent expected by Chembio; Chembio’s operational and financial
success under the agreement depends significantly upon the efforts
of Reszon, and Chembio has limited experience in outsourcing
manufacturing and no experience in outsourcing manufacturing to
Reszon; and there can be no assurance that the manufacturing
operations contemplated by the agreement will be extended beyond
the initial orders of a specified number of HIV 1/2 STAT-PAK
Assay products. 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, 2021 and its Quarterly Report on Form 10-Q
for the quarterly period ended March 31, 2022, 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.
Contact:Philip TaylorGilmartin Group(415)
937-5406investor@chembio.com
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Apr 2023 to Apr 2024