The Company is withdrawing current
submission based on FDA feedback related to shelf-life stability of
a test component
SALT
LAKE CITY, Feb. 21, 2025 /PRNewswire/ --
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or
"Co-Dx"), a molecular diagnostics company with a unique, patented
platform for the development of molecular diagnostic tests,
announced today that, following a collaborative and informative
dialogue with the Food and Drug Administration (FDA), the Company
has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR
COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced
version of the test for 510(k) clearance.
Co-Dx is pleased with the productive engagement with the FDA
related to the initial regulatory submission and with the
performance of the test in clinical evaluations, including
performance data and functionality of the instrument.
The decision by the Company to withdraw the submission was based
on discussions with the FDA regarding the ability to detect a
potential deterioration of one component of the test, related to
shelf-life stability. Following dialogue with the FDA and exploring
the various courses of action available, Co-Dx has determined that
the best long-term solution would be to submit a version of the
test that has been enhanced to address the matter raised in the
510(k) review process.
The Company plans to submit the next iteration of the Co-Dx PCR
COVID-19 test for 510(k) OTC clearance, following the collection of
clinical evaluation data to support the new test's performance. A
new submission also allows the Company to incorporate more
recent Co-Dx PCR platform developments into the COVID-19 test,
which Co-Dx believes will also help to create greater operational
and manufacturing efficiencies, such as consolidating manufacturing
processes to utilize the next generation of test kits and
instruments across all tests on the at-home and point-of-care
platform.
The Company's primary objective is to execute a robust
development and commercialization plan for the Co-Dx PCR platform,
including ongoing innovations to the PCR Pro instrument. The Co-Dx
PCR COVID-19 test is expected to be followed by additional tests
for tuberculosis, upper-respiratory multiplex, and a multiplex HPV
test, among others.
*The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx
PCR Pro™, mobile app, and all associated tests and software) is
subject to review by the FDA and/or other regulatory bodies and is
not available for sale.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a
Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets
state-of-the-art diagnostics technologies. The Company's
technologies are 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 for its Co-Dx PCR at-home and point-of-care platform and to
locate genetic markers for use in applications other than
infectious disease.
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. Forward-looking statements include
statements made with respect to timing for submission of the next
iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance,
that streamlining the COVID-19 test will also help to create
greater operational and manufacturing efficiencies, and our
expectation that additional tests for tuberculosis,
upper-respiratory multiplex, and a multiplex HPV test, among
others, will follow. 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 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. There can be no assurance that any of the anticipated
results will occur on a timely basis or at all due to certain risks
and uncertainties, a discussion of which can be found in our Risk
Factors disclosure in our Annual Report on Form 10-K, filed with
the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the
SEC. 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
