SALT LAKE CITY, Nov. 25, 2020 /PRNewswire/
-- Co-Diagnostics, Inc. (Nasdaq: CODX) (the
"Company"), 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
Saragene™ COVID-19 2-gene multiplex RT-PCR test as an in
vitro diagnostic ("IVD"), intended for the qualitative
detection of the SARS-CoV-2 virus.
The Saragene test kit approved by the CDSCO uses the Company's
patented CoPrimer™ technology and is based on a test originally
designed by Co-Diagnostics, who also recently announced receipt of
a CE marking for its Logix Smart™ SARS-CoV-2 (genes RdRp/E)
multiplex test. Both the CoSara and Co-Diagnostics test target two
gene markers of the SARS-CoV-2 genome, RdRp and
E-gene, to identify the presence of the virus, and were
designed to meet the needs of those markets where government or
regulatory bodies recommend a multi-target coronavirus
diagnostic.
Dwight Egan, CEO of
Co-Diagnostics, commented "Tests built on our CoPrimer technology
have several advantages over other platforms, including the
enhanced multiplex capabilities. We believe that the highly
specific nature of the new Saragene test which follows World Health
Organization guidance will help CoSara be able to play an even more
active role in the battle against this pandemic."
CoSara Director Mohal Sarabhai
remarked "Our honorable Prime Minister Shri
Narendra Modi has endorsed the hike in number of available
RT-PCR tests to keep the COVID-19 positivity rate under 5%. With
this clearance in place, CoSara is geared up for this challenge by
providing affordable, high quality, 'Made in India' 2-gene multiplex COVID-19 RT-PCR tests
across the country."
CoSara has previously received CDSCO clearance for RT-PCR tests
for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C
and human papillomavirus (HPV) to be manufactured and sold as IVDs
in the Indian market.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a
Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets a new,
state-of-the-art diagnostics technology. The Company's technology
is 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 to locate
genetic markers for use in industries other than infectious disease
and license the use of those tests to specific customers.
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 in this release include statements
regarding the (i) use of funding proceeds, (ii) expansion of
product distribution, (iii) acceleration of initiatives in liquid
biopsy and SNP detection, (iv) use of the Company's liquid biopsy
tests by laboratories, (v) capital resources and runway needed to
advance the Company's products and markets, (vi) increased sales in
the near-term, (vii) flexibility in managing the Company's balance
sheet, (viii) anticipation of business expansion, and (ix) benefits
in research and worldwide accessibility of the CoPrimer technology
and its cost-saving and scientific advantages. 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 rely
on any forward-looking statements. Any forward-looking statement
made by the Company in this press release is based only on
information currently available to the Company and speaks only as
of the date on which it is made. 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