The Company intends to use the funds
awarded by the National Institutes of Health for completion of its
upper respiratory panel multiplex on Co-Dx PCR Home™
platform
SALT
LAKE CITY, July 13, 2023 /PRNewswire/ --
Co-Diagnostics, Inc. (Nasdaq: 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
it has been awarded $1.2 million in
funding from the National Institutes of Health (NIH) as part of the
Rapid Acceleration of Diagnostics (RADx®) Tech program for
completion of its upcoming upper respiratory panel on the Company's
Co-Dx PCR Home™ testing platform.
Co-Diagnostics will utilize the funds from the RADx Tech award
to complete development of its flu A/B, COVID-19, and RSV multiplex
test, preparatory for that test to begin clinical trials on the
Co-Dx PCR Home. The Co-Dx PCR Home is currently undergoing clinical
evaluations in anticipation of its submission to the FDA and an
initial product launch for a COVID-19 test.
"We are pleased that the innovation and potential of our new
Co-Dx PCR Home platform has been recognized by the highly
competitive RADx Tech program, with its focus on accessibility and
ease of use for over-the-counter and point-of-care COVID-19
diagnostic solutions," remarked Dwight
Egan, CEO of Co-Diagnostics. "This award is the result of a
monumental effort on behalf of our team that involved a thorough
analysis by industry experts into all aspects of the platform, its
design, history, chemistry of the reagents, and the team
responsible for making our vision a reality.
"Our mission to improve the quality of life through making
high-quality, affordable diagnostics more available worldwide will
be one step closer with the completion of this in-demand
respiratory multiplex, which we believe meets the NIH's standards
for increased accessibility of next-generation testing as we
navigate this post-pandemic landscape."
The NIH launched the RADx initiative on April 29, 2020, with the goal of speeding
innovation in the development, commercialization, and
implementation of technologies for COVID-19 testing, leveraging the
existing NIH Point-of-Care Technology Research Network. The RADx
Tech program is managed by the National Institute of Biomedical
Imaging and Bioengineering (NIBIB), to support the accelerated
development of tests and provide regulatory guidance during the
COVID-19 pandemic and beyond.
This project has been funded in part with federal funds from the
National Institute of Biomedical Imaging (NIBIB), National
Institutes of Health, Department of Health and Human Services,
under Contract No. 75N92023D00001.
The Co-Dx PCR Home testing platform and its associated tests are
subject to FDA review and are 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 Home™ platform and to locate genetic
markers for use in applications other than infectious disease.
Forward-Looking Statements:
This press
release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
(PSLRA) that are subject to a number of risks and uncertainties.
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 completion of our
upcoming upper respiratory panel on the Company's Co-Dx PCR Home™
testing platform, initiation of clinical trials on the Co-Dx
PCR Home in the upcoming flu season, and our belief our platform
will meet the NIH's standards for increased accessibility of
next-generation testing. 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 16,
2023, 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