Ongoing Phase II preclinical study data for Co-Dx PCR MTB and HPV tests support advancement to clinical performance testing

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, today announced that CoSara Diagnostics Pvt. Ltd. ("CoSara"), the joint venture ("JV") between Ambalal Sarabhai Enterprises Limited (ASE Group) and Co-Dx, will participate and host a booth at VIROCON 2025, taking place December 8-10 at the Conrad Hotel in Pune, Maharashtra, India.

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CoSara is currently supporting the second phase of the Company's preclinical studies for the Co-Dx PCR MTB (tuberculosis) test and Co-Dx PCR HPV multiplex test on the Co-Dx PCR point-of-care (PoC) platform*. Phase I of the MTB test studies included 354 clinical specimens from sputum and tongue swabs to provide early sensitivity and specificity assessments, while Phase II has evaluated 211 sputum specimens in a comparison evaluation against other tests to establish concordance for Mycobacterium tuberculosis detection. The studies are being conducted in preparation of advancement to clinical performance testing, required by Indian regulatory authorities prior to submission.

Phase I of the preclinical studies for the 8-type HPV multiplex test, designed to identify the presence of eight different human papillomavirus genotypes, evaluated 286 clinical specimens to validate and optimize the Co-Primers(R) test chemistry for HPV. Three of the eight genotypes are classified as high-risk for cancer, and in Phase II, 53 specimens have been analyzed to date to facilitate the differential detection of the three high-risk HPV genotypes as the application algorithm continues to be trained, refined and optimized.

The Company believes that data gathered thus far in the preclinical studies for both tests support advancement to clinical performance testing, as part of the pathway to regulatory submissions.

Attendees interested in learning more about CoSara products, including the TB and HPV tests on the Company's upcoming Co-Dx PCR platform, are encouraged to stop by at VIROCON 2025. CoSara will be available for meetings and interactions at CoSara's booth.

VIROCON 2025is organized by the India Council of Medical Research - National Institute of Virology ("ICMR-NIV"), with this year's theme being "Changing Landscape in Human, Animal, and Plant Viruses: Bridging Basic Science, Innovations and Public Health." The conference is expected to provide a platform for productive scientific deliberations and collaborations aimed at developing solutions to contain the viral epidemics that threaten human, animal, plant, aquatic and environmental health.

*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.

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 to detect and/or analyze 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 (subject to regulatory review and not currently for sale) and to identify 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 tests, including statements about potential or future clinical performance studies, regulatory submissions, product performance, market opportunities, or commercialization efforts related to the Co-Dx PCR platform and associated tests. 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 27, 2025, 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

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