Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

"The submission of this 510(k) premarket notification and CLIA Waiver by Application represents one of the most significant milestones in Co-Diagnostics' history and reflects years of investment in developing the Co-Dx PCR platform," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "With this submission, we are entering the next phase of our regulatory pathway as we move towards our goal of bringing decentralized PCR diagnostics closer to the patient through a platform designed to improve accessibility, affordability and ease of use, with a cloud-based infrastructure built to power situational awareness as infections spread through communities."

The submission is supported by the clinical and analytical performance studies previously reported by the Company, including a clinical study enrolling more than 1,400 symptomatic patients across nine geographically distinct U.S. clinical sites, and an analytical program spanning 27 studies and over 10,000 upper respiratory PCR test runs. The analytical work included a multicenter reproducibility study, which evaluated performance across multiple operators, sites and instruments. Together, these studies support the Company's concurrent CLIA Waiver by Application, which, if granted, would enable use of the test in decentralized waived point-of-care settings and contribute to expanded access to molecular PCR testing outside traditional laboratory environments.

The Co-Dx PCR platform combines real-time PCR quality with a lower-cost instrument and consumable model, and integrates an innovative cloud-based infrastructure with data aggregation with the goal of helping to track localized outbreaks as they occur. These features differentiate the platform from existing decentralized and point-of-care molecular systems and support the Company's expansion into near-patient and decentralized testing environments.

*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 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 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 and concurrent CLIA Waiver by Application, the timing and outcome of FDA review, the Company's ability to obtain regulatory clearance or a CLIA waiver for the Co-Dx™ PCR Flu A/B & RSV test, the expected performance and commercialization of the test and the Co-Dx PCR Pro^® instrument, the Company's plans to expand the Co-Dx PCR platform with additional assays and applications, 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: including 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 or a CLIA waiver; risks that any clearance or waiver 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; 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-submits-fda-510k-premarket-notification-for-upper-respiratory-point-of-care-test-302844796.html

SOURCE Co-Diagnostics