PR Newswire
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 5 th 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 3 rd 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.
SOURCE Co-Diagnostics