SALT LAKE CITY, May 4, 2020 /PRNewswire/ -- Co-Diagnostics,
Inc. (Nasdaq: CODX), a molecular diagnostics company
with a unique, patented platform for the development of molecular
diagnostic tests, announced today that its Logix Smart™ Coronavirus
COVID-19 Test has been approved for sale in Mexico by the Mexican Department of
Epidemiology ("InDRE") after InDRE successfully concluded an
evaluation of the test's sensitivity and specificity and its
non-reactivity with other respiratory viruses. InDRE, which is
analogous to the U.S. Centers for Disease Control and Prevention
(CDC), is required to evaluate any test to detect the disease
before the test may gain clearance to be sold into the Mexican
healthcare market.
Co-Diagnostics also announced that CoSara, the Company's joint
venture for manufacturing in India, expects to now begin filling orders
following the successful evaluation of CoSara's Saragene™ COVID-19
RT-PCR test kit by the Indian Council of Medical Research (ICMR).
The evaluation showed 100% sensitivity and 100% specificity without
any cross reactivity with other respiratory viruses, and it has
been cleared for sale to the Indian market.
CoSara has received a license from the Central Drugs Standards
Control Organisation (CDSCO) to manufacture the Saragene COVID-19
test kits. The test approved by the CDSCO was the same as that
originally designed by Co-Diagnostics, and will be manufactured in
CoSara's GMP manufacturing facility in Ranoli, India which is capable of large scale
production.
Dwight Egan, Co-Diagnostics CEO,
remarked "Orders for our Logix Smart COVID-19 test continue to be
strong. We believe our continued growth is due to our ability to
meet testing needs on a timely basis, with a high quality,
cost-efficient, easy to process test. We are pleased that our
technology is also being deployed in many areas in the United States, providing high-throughput
diagnostic solutions to improve the quality of COVID-19 detection
in those communities. The Company has participated in governmental
and private initiatives designed to increase test
availability."
The Company's Logix Smart COVID-19 test is currently available
to all clinical laboratories certified under Clinical Laboratory
Improvement Amendments (CLIA), and is authorized to be used for the
diagnosis of SARS-CoV-2, the virus that causes COVID-19.
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
place undue reliance on any forward-looking statements. 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