Co-Diagnostics Performs Analysis of Influenza Co-Primers® to Confirm Reactivity Against Flu A H3N2 Mutation

SALT LAKE CITY, Dec. 17, 2025 /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, today announced that it has performed an in silico analysis of the Co-Primers® used in its Logix Smart® ABC test* for the detection of influenza A, influenza B and COVID-19. The analysis showed a high homology against 3,900 influenza sequences, confirming comparable reactivity of the primer sets against the influenza A H3N2 subclade K.

According to the World Health Organization, seasonal influenza causes approximately 3–5 million cases of severe illness annually, resulting in 290,000–650,000 respiratory fatalities. This year's flu vaccine is mismatched with subclade K (or "J.2.4.1"), which has limited natural immunity within communities. influenza A subtype H3N2 has historically been associated with higher rates of hospitalization and death, and preliminary data has already linked subclade K to countries like Japan and the United Kingdom experiencing earlier than usual flu seasons in 2025, following Australia reporting a record flu season.

"We have received customer inquiries regarding the performance of the Logix Smart ABC test against this year's influenza strains," remarked Dwight Egan, CEO of Co-Dx. "Based on the results of this analysis, we are confident that the test retains comparable sensitivity as when it was first developed on our proprietary platform more than five years ago. This consistency underscores the stability of our technology and our commitment to expanding access to high-quality PCR testing solutions."

In November 2020, the Logix Smart ABC test received CE-marking for the simultaneous detection of and differentiation of influenza A, influenza B, and SARS-CoV-2, the virus that causes COVID-19. The test's Co-Primers target a region on the MP gene of influenza A, whereas the mutations associated with subclade K occur in the HA region of the genome. The in silico analysis concluded that there is no concern that any emerging H3N2 strains would affect the test kit's sensitivity. The Logix Smart ABC test is intended for use by qualified and trained clinical laboratory personnel.

In November 2025, the Company announced that it had initiated clinical performance testing for the Co-Dx PCR Flu A/B, COVID-19, RSV point-of-care upper-respiratory multiplex test**, which is intended to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. Similar to the Logix Smart test, the flu A targets in this test are not expected to be affected by H3N2 subclade K.

*This test is not approved or cleared by the U.S. Food and Drug Administration (FDA). It is for export only and is not for sale in the United States.

**The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies 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 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, including statements regarding the expected performance and sensitivity of the Company's diagnostic tests, the impact of influenza virus mutations, ongoing and planned clinical testing, and potential regulatory submissions and approvals. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Such risks and uncertainties include, but are not limited to, changes in viral genomics, regulatory review processes, clinical and analytical performance results, manufacturing and supply considerations, market conditions, and other risks described from time to time in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by law.

SOURCE Co-Diagnostics