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

Core Viewpoint - Co-Diagnostics, Inc. has conducted an in silico analysis of its Logix Smart ABC test, confirming its effectiveness against the influenza A H3N2 subclade K, which is significant due to the current flu season and vaccine mismatch [1][2][3]. Group 1: Company Developments - The Logix Smart ABC test has shown high homology against 3,900 influenza sequences, indicating comparable reactivity against the H3N2 subclade K [1]. - The test received CE-marking in November 2020 for the simultaneous detection of influenza A, influenza B, and SARS-CoV-2, with no concerns regarding sensitivity from emerging H3N2 strains [3]. - In November 2025, the company initiated clinical performance testing for a new PCR Flu A/B, COVID-19, RSV point-of-care multiplex test, aimed at FDA 510(k) clearance [4]. Group 2: Industry Context - The World Health Organization reports that seasonal influenza leads to approximately 3–5 million severe illness cases and 290,000–650,000 respiratory fatalities annually [2]. - The current flu vaccine is mismatched with the H3N2 subclade K, which has limited natural immunity in communities, raising concerns about higher hospitalization and death rates [2]. - Preliminary data indicates that countries like Japan and the UK are experiencing earlier flu seasons in 2025, following a record flu season in Australia [2].