Co-Diagnostics, Inc Completes Successful Clinical Evaluation Required for FDA Emergency Use Authorization
March 20 2020 - 06:30AM
Business Wire
Company accelerates U.S. sales of COVID-19
test pursuant to new FDA policy
Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular
diagnostics company with a unique, patented platform for the
development of diagnostic tests, announced today that following a
successful clinical evaluation of its Logix Smart™ COVID-19 Test,
the Company will begin fulfilling orders from a wider array of U.S.
customers, including thousands of additional laboratories in the
country who can now run the Company’s test as a clinical
diagnostic.
A recent FDA policy change aimed at expediting the availability
of COVID-19 diagnostics has allowed the Company to expand domestic
sales of its test immediately. Co-Diagnostics’ COVID-19 polymerase
chain reaction (PCR) test can yield results in under two hours, and
successfully passed the clinical evaluation as requested in the
policy change, showing sensitivity of 100% and specificity of 100%
in detecting SARS-CoV-2, the virus which causes COVID-19, without
demonstrating any cross-reactivity with other coronaviruses.
Dwight Egan, Co-Diagnostics CEO, commented, “Our Logix Smart
COVID-19 test has already been deployed on a global basis to five
continents as well as to U.S. CLIA labs that meet certain
requirements, and we are prepared to provide an even greater number
of U.S. laboratories and patients access to our test as a result of
the new FDA policy. The demand for reliable, high-quality COVID-19
diagnostics has never been greater, and it continues to grow daily
as this disease affects not just patients afflicted with it and
their families, but the entire nation as a whole.
“We believe the excellent performance of our COVID-19 test
combined with affordable pricing will place it in the vanguard of
available testing alternatives worldwide. We have scaled up both
our domestic and international production capabilities to meet
demand, including receiving a license to manufacture our COVID-19
test in our facility in India, which more than triples our
capacity. The Company’s Logix Smart COVID-19 test, built on our
patented CoPrimer™ technology, has the potential to improve the
quality of life of millions of Americans by providing access to a
prompt, accurate, cost-effective test. We are gratified to be in a
position to make available a test that can provide results in less
than two hours, which we believe is among the fastest turn-around
times of any test currently on the market.”
The new FDA policy permits Co-Diagnostics to begin U.S. sales of
COVID-19 tests immediately while it awaits FDA clearance under
Emergency Use Authorization (EUA). The Company’s application for
EUA is 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 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 may include statements regarding the (i) use of
funding proceeds, (ii) expansion of product distribution, (iii)
acceleration of initiatives in certain verticals or markets, (iv)
capital resources and runway needed to advance the Company’s
products and markets, (v) increased sales in the near-term, (vi)
flexibility in managing the Company’s balance sheet, (vii)
anticipation of business expansion, and (viii) 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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version on businesswire.com: https://www.businesswire.com/news/home/20200320005142/en/
Company Contact: Andrew Benson Head of Investor Relations
+1 801-438-1036 investors@codiagnostics.com
Media Contact: Jennifer Webb Coltrin & Associates,
Inc +1 267-912-1173 jennifer_webb@coltrin.com
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