Co-Diagnostics Analyzes Influenza Co-Primers for Reactivity against Flu A H3N2 Variants

Co-Diagnostics Evaluates Influenza Co-Primers Against H3N2 Mutations

Co-Diagnostics, Inc., a prominent player in molecular diagnostics, has recently conducted an in silico analysis of its proprietary Co-Primers® used in the Logix Smart® ABC test. This evaluation aimed to assess the test's capability to detect various influenza strains, particularly the H3N2 mutation, which has raised substantial concern this flu season.

According to the company's findings, there is a significant alignment of the primers with over 3,900 influenza sequences, affirming their efficacy against the influenza A H3N2 subtype K. The World Health Organization reports that seasonal influenza inflicts between 3 to 5 million severe illnesses annually, resulting in 290,000 to 650,000 deaths from respiratory issues. Alarmingly, the current year's flu vaccine appears to be mismatched with subclade K, which has limited immunity in numerous communities. Historically, H3N2 has been linked to higher hospitalization and mortality rates. In 2025, preliminary data suggested that the subclade K may be contributing to earlier-than-usual flu seasons in regions including Japan and the UK, following a record-breaking flu season in Australia.

In light of increasing inquiries from clients about the performance of the Logix Smart ABC test against this year's flu strains, CEO Dwight Egan reassured, "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."

Originally receiving CE-marking in November 2020, the Logix Smart ABC test employs Co-Primers targeting the MP gene of influenza A, while the H3N2 subclade K mutations are found in the HA region of the virus' genome. Notably, the in silico analysis indicates no anticipated risk that evolving H3N2 strains would impair the sensitivity of this test kit. Moreover, the Logix Smart ABC test is designated for use by trained clinical laboratory personnel, ensuring accurate and reliable results.

Furthermore, in November 2025, Co-Diagnostics initiated clinical performance testing for its Co-Dx PCR Flu A/B, COVID-19, and RSV point-of-care upper-respiratory multiplex test. This effort aims to facilitate a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. Similar to its Logix Smart counterpart, it is expected that the flu A targets in this new test will remain unaffected by the H3N2 subclade K mutations.

It is important to note that while the Logix Smart ABC test is not approved or cleared by the FDA for sale in the United States and is designated for export only, it illustrates Co-Diagnostics’ commitment to responding proactively to changing viral dynamics. The company is at the forefront of advancing molecular diagnostics technology and continues to innovate in an effort to ensure public health safety amidst evolving infectious diseases.

Co-Diagnostics, based in Utah, specializes in developing and commercializing sophisticated diagnostic technologies that help detect and analyze DNA or RNA molecules. Leveraging its proprietary technology, the firm customizes specific tests for its Co-Dx PCR platform, further amplifying its role in managing and understanding infectious diseases. The company continues to navigate the complexities associated with evolving respiratory viruses, ensuring that its testing solutions adapt to meet public health needs effectively.

Looking Ahead

The ongoing surveillance and evaluation of influenza and COVID-19 strains are vital as emerging variants pose potential risks to public health. Co-Diagnostics remains vigilant in its research and innovation efforts, fostering advancements in the healthcare sector. With the vital role of molecular diagnostics in controlling infectious diseases, the work conducted by firms like Co-Diagnostics will continue to be essential in protecting global health.

As we move through this flu season, healthcare professionals are encouraged to stay informed about innovations in diagnostic methods, ensuring they can act swiftly against the evolving threats posed by influenza and other respiratory viruses.