The Company's Emergency Use Authorization
submission is for the new Co-Dx PCR Pro instrument and COVID-19
test kit, designed for point-of-care and at-home. The menu of tests
in development for the platform includes TB, HPV, and a multiplex
respiratory panel for flu A/B, COVID-19, and RSV
SALT
LAKE CITY, Dec. 27, 2023 /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, today
announced that it has submitted its Co-Dx™ PCR COVID-19 test with
Co-Dx PCR Pro™ instrument for review by the U.S. Food and Drug
Administration (FDA) for Emergency Use Authorization (EUA). The
submission includes the PCR Pro instrument, COVID-19 detection
test, and mobile app, all designed for use in point-of-care and
at-home settings.
Tests run on the new platform use the Company's patented
real-time polymerase chain reaction (PCR) Co-Primers™ technology.
The Co-Dx COVID-19 test kit for the PCR Pro instrument included in
the Company's FDA submission has been shown in clinical evaluations
to detect the presence of COVID-19 in anterior nasal swab samples,
with results displayed on the user's smartphone or mobile device in
approximately 30 minutes.
The menu of future tests that are currently in development for
the new platform includes tuberculosis (TB) and human
papillomavirus (HPV), as well as an upper respiratory multiplex
panel that will detect influenza A/B, COVID-19, and respiratory
syncytial virus (RSV) within a single sample. All three tests have
also been the subject of grant support by notable funding bodies
over the last half of this year.
"This new platform technology is a significant step towards
advancing the Company's mission to increase accessibility of PCR
diagnostics," said Dwight Egan, CEO
of Co-Diagnostics. "In addition to the development of new
technologies from the ground-up by a world-class team to
decentralize PCR diagnostics technology and make it available at
the point-of-care and in at-home settings, it also required the new
technology to be able to be commercialized at a price point that is
relevant worldwide. Diagnostics, along with vaccines and
therapeutics, are a vital tool in helping to combat illnesses like
TB, which remains a significant problem in India and many other countries despite being a
highly treatable disease. We are pleased to announce this
submission to the FDA for this new platform."
*The Co-Dx PCR at-home and point-of-care platform (including
the PCR Home™, PCR Pro, mobile app, and all associated test kits)
is subject to review by the FDA and/or other regulatory bodies and
is not yet 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. 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. No
assurance can be given that the FDA will grant emergency use
authorization for the Co-Dx PCR platform or that the
Company will be successful in developing additional diagnostic
tests for use with the platform. 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 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