The clinical laboratory real-time PCR
multiplex test was designed using Co-Dx Co-Primers™ and licensed by
the CDSCO for use in diagnostic procedures
SALT
LAKE CITY, March 7, 2024 /PRNewswire/ --
Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a
molecular diagnostics company with a unique, patented platform for
the development of molecular diagnostic tests, announced today that
CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint
venture for manufacturing and sales in India, has received clearance by the Central
Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAPLEX™
Influenza Multiplex (IFM) Test Kit to clinical laboratories as an
in vitro diagnostic ("IVD") for the detection and
differentiation of Influenza A and Influenza B.
CoSara's new real-time multiplex PCR test is built on the
Company's patented Co-Primers™ technology and designed to
simultaneously detect influenza A (H1N1, H3N2, H7N9, H1N2, H5N1,
H2N2, H9N2, H10N8, H5N6, H7N7, H7N4, H7N2 and H2N1), influenza B
(Yamagata and Victoria strains)
and to differentiate between H1N1 and H3N2. Co-Primers utilize a
unique design architecture to combat common issues with real-time
PCR that can lead to inaccurate results, specifically primer dimer
propagation, and which are magnified in multiplex reactions.
"The importance of accurate, reliable PCR testing at the
high-throughput clinical laboratory level remains critical,"
remarked Dwight Egan, CEO of
Co-Diagnostics. "We are pleased that our Co-Primers technology will
help to combat respiratory illnesses in India as the world continues to adjust in the
wake of the pandemic, and while we work with CoSara in preparation
for playing an important role in the next stage of our Company's
growth with the upcoming launch of our Co-Dx™ PCR Pro™
instrument*."
CoSara Director Mohal Sarabhai
commented, "This test marks the 15th of CoSara's
clinical lab tests to receive IVD clearance by the CDSCO, and adds
to our expanding menu of valuable diagnostic tools available to our
growing distributor and laboratory customer base. It strengthens
our foundation for future growth as CoSara also assists in the
progress of point-of-care testing across India, and prepares to provide manufacturing,
distribution, and regulatory support for the forthcoming Co-Dx PCR
platform."
CoSara has previously received CDSCO clearance for RT-PCR tests
for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis B
viral load, hepatitis C, hepatitis C viral load, HPV types 16 and
18 and HPV-HR, two COVID-19 assays, chikungunya, dengue, a
dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 ("ABC")
multiplex test, all designed using the Company's patented
Co-Primers technology and cleared to be manufactured and sold to
clinical laboratories in the Indian market as IVDs.
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™,
mobile app, and all associated tests) is subject to review by the
FDA and/or other regulatory bodies and is not yet available for
sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are
currently under review by the FDA.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a
Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets
state-of-the-art diagnostics technologies. The Company's
technologies are utilized for tests that are designed using the
detection and/or analysis of nucleic acid molecules (DNA or RNA).
The Company also uses its proprietary technology to design specific
tests for its Co-Dx PCR at-home and point-of-care platform and to
locate genetic markers for use in applications other than
infectious disease.
Forward-Looking Statements:
This press release
contains forward-looking statements. Forward-looking statements can
be identified by words such as "believes," "expects," "estimates,"
"intends," "may," "plans," "will" and similar expressions, or the
negative of these words. Such forward-looking statements are based
on facts and conditions as they exist at the time such statements
are made and predictions as to future facts and conditions.
Forward-looking statements are subject to inherent uncertainties,
risks and changes in circumstances. Actual results may differ
materially from those contemplated or anticipated by such
forward-looking statements. Readers of this press release are
cautioned not to place undue reliance on any forward-looking
statements. There can be no assurance that any of the anticipated
results will occur on a timely basis or at all due to certain risks
and uncertainties, a discussion of which can be found in our Risk
Factors disclosure in our Annual Report on Form 10-K, filed with
the Securities and Exchange Commission (SEC) on March 16, 2023, and in our other filings with the
SEC. The Company does not undertake any obligation to update any
forward-looking statement relating to matters discussed in this
press release, except as may be required by applicable securities
laws.
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SOURCE Co-Diagnostics