Co-Diagnostics, Inc. to Provide COVID-19 Tests to US CLIA Labs Following FDA Policy Change
March 02 2020 - 6:30AM
Business Wire
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
recent change to the Food and Drug Administration’s (FDA) policy
towards the coronavirus outbreak, the Company’s coronavirus test
kits are available to laboratories certified under the Clinical
Laboratory Improvement Amendments (CLIA) for use according to the
FDA guidelines.
The Company is in discussions with certain qualified CLIA
laboratories who can use COVID-19 tests built on Co-Diagnostics'
platform technology in their Emergency Use Authorization (EUA)
submissions with the FDA. Once the labs have completed the process
required for the EUA submission, it is expected that they would
purchase the Company’s reagents for use in their COVID-19
diagnostics, as permitted by the FDA.
Dwight Egan, CEO of Co-Diagnostics, commented, “We believe this
change will allow the diagnostics industry to respond to the
developing situation much more rapidly and effectively, and we
applaud the FDA for taking such aggressive action to address the
coronavirus outbreak. Co-Diagnostics’ patented CoPrimer™ technology
has been vetted in numerous applications by some of the most
highly-respected firms focusing on molecular technology, and we are
pleased to make this platform available domestically immediately to
support the FDA’s mission to slow the spread of this disease and
mitigate its impact.
“In addition to these efforts with US CLIA labs following the
change in US policy, our CE-IVD Logix Smart™ COVID-19 test kit has
already been shipped to countries on several continents, both for
performance evaluation as well as for use as a diagnostic tool
where its CE marking makes that possible.”
The policy change is a result of the FDA’s commitment to
aggressively address the current coronavirus outbreak, and allows
CLIA laboratories to use tests that have been developed and
validated for detection or diagnosis of the novel coronavirus
before the FDA has completed the review of the laboratories’
submission under Emergency Use Authorization (EUA) guidance. Prior
to the chance in policy, all laboratories wishing to test for
COVID-19 were required to complete their EUA submission and receive
clearance from 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/20200302005318/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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