SALT
LAKE CITY, Aug. 29, 2023 /PRNewswire/
-- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx™" or the
"Company"), a molecular diagnostics company with a unique, patented
platform for the development of molecular diagnostic tests,
announced today that it is pleased to welcome Ivory Chang as the Company's Chief Regulatory
Affairs Officer.
Ms. Chang's in-depth regulatory affairs experience has included
time spent with several notable names in the diagnostics industry,
including Roche, Boston Scientific, BD Biosciences, Cepheid, Thermo
Fisher Scientific, and more. Her background has involved regulatory
and registration submissions to major regulatory bodies around the
world for infectious disease, oncology, point-of-care, in
vitro diagnostics (IVD), and software diagnostic products.
Dwight Egan, Company CEO,
commented "We are pleased to welcome someone with Ms. Chang's vast
industry experience to the management team at Co-Dx. We believe
Ivory's skillset and impact in advancing our future regulatory
submissions for our planned, expanding pipeline of products will
help to further the Co-Dx vision of increasing the accessibility of
state-of-the-art molecular diagnostic solutions, both for our
legacy in vitro diagnostics products as well as our
forthcoming Co-Dx PCR Home™ platform."
"I am excited to be able to draw on my years of regulatory
experience when we pursue clearance for the Company's exciting new
platform and prepare it for the initial launch," remarked Ms.
Chang. "The innovation of the Co-Dx PCR Home platform
attracted me to playing an active role in supporting the Company's
efforts as the world shifts to a more decentralized
approach to diagnostics, as well as the efforts of our existing and
planned IVDs for high-complexity clinical laboratories."
The Co-Dx PCR Home platform is subject to FDA review 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 to locate genetic markers for use in industries other than
infectious disease and license the use of those tests to specific
customers.
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. Risks and
uncertainties that may cause such differences include, among other
things: our products may not prove to be as effective as other
products currently being commercialized or to be commercialized in
the future by competitors; risks inherent in manufacturing and
scaling up to commercial quantities while maintaining quality
controls; the uncertainties inherent in new product development,
including the cost and time required to gain regulatory clearance
for such product and to commercialize such product(s);and, market
acceptance of our products once commercialized. Readers are
cautioned not to place undue reliance on the forward-looking
statements, which speak only as of the date on which they are made
and reflect management's current estimates, projections,
expectations, and beliefs. 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 the 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