Presentation included announcement of the
opening of the new manufacturing
facility in Salt Lake City,
UT
SALT LAKE CITY, March 21, 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 in
his keynote address at the 5th Annual MarketsandMarkets
conference in London, Company CEO
Dwight Egan shared an update on the
new manufacturing facilities in Salt Lake
City, Utah and in Ranoli, India, including announcing the grand opening
of the new Utah facility next
month.
Both Co-Dx and CoSara Diagnostics, the Company's joint
venture for manufacturing in India, will be manufacturing the
Co-Dx™ PCR Pro™ instrument and Co-Dx PCR test cups that
run on the Company's new PCR platform*. Mr. Egan shared that the
CoSara facility is in the process of being expanded to allow for
greater capacity, and that both facilities would also be
manufacturing the Company's patented Co-Primers™ oligonucleotides,
a key reagent component in all Co-Dx and CoSara test products both
for clinical laboratories and the new platform, and which had
previously been outsourced to 3rd party
manufacturers.
In-house manufacturing of the reagents as well as equipment and
consumables is anticipated to play an important role as the Company
prepares for commercialization of its new platform. In addition to
the Co-Dx PCR COVID-19 test on the platform, which is currently
pending FDA review, Mr. Egan discussed other forthcoming platform
products, including tuberculosis (TB), which caused an estimated
1.3 million deaths out of an estimated 10.6 million infections in
2022 despite being highly treatable (source: WHO). The estimated TB
incidence rate in India alone was
2.82 million, leading to nearly 350,000 deaths for the year.
"We anticipate that this new platform has the potential to have
a positive impact as we join the fight against diseases like TB,
especially in India," said Mr.
Egan, elaborating on his keynote remarks. "TB is the deadliest
single disease in the world, and we believe that our vision to help
to close the equitable diagnostics access gap aligns with the
missions of groups like The Bill & Melinda Gates Foundation and
the World Health Organization, especially as we approach the
upcoming World TB Day on March
24.
"A principal component of our successful commercialization
strategy is increased manufacturing capacity, and manufacturing in
India is also an important aspect
of qualifying under the "Make in India" initiative to remove roadblocks to
establishing a foothold in the Indian point-of-care testing market.
We are pleased with the progress we have made so far and look
forward to the anticipated developments throughout the remainder of
this year and beyond."
The ribbon cutting ceremony of the Company's Salt Lake City production facility is
scheduled for April 11, 2024, for
Company employees and invitees.
*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. Forward-looking statements include
statements made with respect to our Co-Dx PCR platform and
forthcoming tests for TB, 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