SALT LAKE CITY, April 6, 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 obtained Emergency
Use Authorization (EUA) by the Food and Drug Administration (FDA)
to be used for the diagnosis of SARS-CoV-2. The Company's test can
be used by clinical laboratories certified under Clinical
Laboratory Improvement Amendments (CLIA) to detect the presence of
the virus that causes COVID-19, and is available for purchase from
the Company's Utah-based
ISO-13485:2016 certified facility.
Co-Diagnostics began offering its COVID-19 test to some U.S.
CLIA labs in March 2020 as a result
of the FDA's policy for diagnostic tests for COVID-19 during the
current public health emergency. Previously, the Company had
initiated sales of its CE-IVD test to the European Community, and
to other global markets that accept a CE marking as valid
regulatory approval following routine local product
registration.
CEO of Co-Diagnostics Dwight Egan commented, "We believe that
this authorization confirms the quality and performance of our
COVID-19 test, and that it is a significant step in opening more
doors and helping this test to reach an even wider audience. Many
experts agree that accessibility of widespread testing is an
important element to 'flattening the curve' as U.S. cases of
COVID-19 continue to rise, and that increased testing throughput is
vital to achieve this objective. We look forward to continuing our
goal of increasing the availability of advanced, high-throughput,
and cost-effective COVID-19 testing solutions both close to home
and across the globe."
The Co-Diagnostics Logix Smart™ Coronavirus COVID-19 Test uses
the Company's patented CoPrimer™ technology to target the
RdRp gene of the SARS-CoV-2 virus. The advanced nature of
CoPrimers has allowed Co-Diagnostics to design a highly-specific,
single-well PCR test, allowing higher throughput over tests that
require multiple wells. Co-Diagnostics believes the lower cost of
reagents in the Company's single-well test will help hospitals and
laboratories to process more while paying less, benefiting
healthcare providers and patients alike.
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