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.
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.