The Company expects that the application
for OTC clearance will shortly be followed by pursuit of POC
clearance, with other tests in the pipeline to meet the needs of a
global market
SALT
LAKE CITY, June 14, 2024 /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 the Company has completed its first U.S. Food
and Drug Administration (FDA) application for 510(k) clearance for
the Co-Dx™ PCR Pro™ instrument, and the Co-Dx PCR COVID-19 Test for
over-the-counter (OTC) use.
Co-Diagnostics completed the submission via the FDA's electronic
Submissions Template And Resource (eSTAR) system, and have received
the acknowledgement from the FDA that the 510(k) application was
received. eSTAR serves as a comprehensive resource for medical
device manufacturers to standardize and consolidate the necessary
information and links needed for 510(k) submission preparation.
The Co-Dx PCR platform has been designed to help close the
access gap for infectious disease diagnosis by facilitating the
widespread decentralization of gold-standard PCR diagnostics, which
have historically only been found in high-complexity clinical
laboratories. It consists of a compact and robust real-time PCR
instrument operated at point-of-care or in at-home settings via an
intuitive smartphone interface, with test cups powered by patented
Co-Dx Co-Primers® technology.
The Company is also preparing to shortly pursue clearance for
the Co-Dx PCR COVID-19 test on the new instrument, to be used for
point-of-care testing (POCT).
Other diagnostics for the platform in varying stages of
development or preparation for clinical evaluations include tests
for tuberculosis, human papillomavirus, strep A, and a respiratory
multiplex that detects influenza A and B, COVID-19 and RSV in a
single test.
"This FDA application is an important milestone in our Company's
growth and represents a crucial step towards closing the gap that
separates many patients and communities around the world from
gold-standard diagnostics," said Dwight
Egan, Company CEO. "If granted, we believe that the
credibility of 510(k) clearance for diagnostic use would greatly
validate the quality of our new platform as we proceed with the
completion of tests for other indications and for use in other
regions of the world.
"While we have identified markets for this initial diagnostic
offering and we are eager to begin commercialization once cleared
to do so, we expect that the other tests to follow will be even
more transformative, and we are quickly moving to complete the
requirements to initiate clinical evaluations and submit regulatory
filings for these tests in their respective target markets."
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™,
mobile app, and all associated tests) is subject to review by the
FDA and/or other regulatory bodies and is not yet available for
sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are
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
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. Forward-looking statements in this
release include statements concerning our intention to pursue
clearance for POCT use of the COVID-19 test kit on the new
instrument in the near future, and our plans to begin clinical
evaluations and complete regulatory submissions for the other tests
in our pipeline. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-inc-submits-first-fda-510k-application-for-co-dx-pcr-pro-platform-302172833.html
SOURCE Co-Diagnostics