Co-Diagnostics Participates in Medical Devices and Innovations Roundtable Media Event

The 90-minute event included discussion of topics such as the significance of recent innovations and challenges surrounding the medical device industry in Utah, the current and future impact of artificial intelligence on the industry, how data interoperability is shaping product development and forecasts for adoption, and what factors are currently shaping companies' strategies in bringing technologies from concept to commercialization.

Co-Dx recently announced a 510(k) premarket notification submission to the FDA for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro^® instrument. The Company conceived of the Co-Dx PCR point-of-care platform* during the height of the pandemic. Following several years of investment, development and optimization and subject to FDA clearance, the Company is undertaking commercial-readiness activities for a potential U.S. launch of the platform while also pursuing other regulatory authorizations internationally and working to expand access to PCR diagnostics on a global scale.

*The Co-Dx PCR platform (including the PCR Home^®, PCR Pro^®, mobile app, and all associated tests) has not been cleared or authorized by the FDA, 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 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 (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 within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding the Company's 510(k) notification, the timing and outcome of FDA review, the potential clearance, regulatory authorization and commercialization of the Co-Dx PCR Flu A/B & RSV test, the Co-Dx PCR Pro® instrument and the broader Co-Dx PCR platform, and the Company's ability to commercialize the platform in decentralized point-of-care settings. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that the FDA may decline to accept the submission, request additional information, testing or modifications, delay its review, or determine not to grant clearance; risks that any clearance may be subject to limitations, conditions or labeling that restrict the contemplated use of the test or platform; risks relating to the accuracy, reliability, reproducibility and performance of the test and platform; risks associated with manufacturing scale-up, supply chains, quality systems and reliance on third parties; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technology; risks related to competition, technological change, and intellectual property protection; risks associated with obtaining, maintaining and complying with regulatory authorizations in jurisdictions outside the United States; and other risks described from time to time in the Company's filings with the Securities and Exchange Commission ("SEC"). Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

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SOURCE Co-Diagnostics