1. Co-Diagnostics confirms Logix Smart ABC test's reactivity against flu subclade K. 2. Influenza subclade K linked to high severity and early flu seasons. 3. Test maintains sensitivity from initial development over five years ago. 4. New multiplex test under regulatory review for FDA approval. 5. Market conditions and regulatory changes pose risks for Co-Diagnostics.
FAQ
Why Bullish?
The successful analysis demonstrating sensitivity increases confidence in CODX's market position. Historical examples show that strong performance fundamentals often lead to positive market reactions.
How important is it?
Increased product confidence and potential FDA approval can significantly influence CODX's stock positively. Investor sentiment may shift based on continual performance metrics and health trends.
Why Short Term?
The immediate positive test results may lead to increased sales and interest in CODX's products, but regulatory processes take longer. Previous FDA approvals have shown that market responses are often short-lived until actual sales figures come in.
Co-Diagnostics Conducts Analysis to Confirm Flu A H3N2 Reactivity
Co-Diagnostics, Inc. (Nasdaq: CODX), a leading molecular diagnostics company, has announced significant findings from its latest in silico analysis of Co-Primers®. This examination is centered around the Logix Smart® ABC test, a diagnostic tool designed for the detection of influenza A, influenza B, and COVID-19. The results reveal robust homology against over 3,900 influenza sequences, confirming that the test maintains comparable reactivity against the influenza A H3N2 subclade K.
Impact of Seasonal Influenza on Public Health
According to the World Health Organization, seasonal influenza is responsible for around 3–5 million cases of severe illness annually, leading to approximately 290,000–650,000 deaths from respiratory diseases. The current flu vaccine is mismatched with the subclade K (designated "J.2.4.1"), resulting in limited natural immunity amongst populations. The H3N2 subtype of influenza A has a historical tendency towards higher hospitalization and mortality rates.
Preliminary data indicates that countries like Japan and the United Kingdom may face earlier flu seasons in **2025**, following Australia’s record flu season. These trends heighten the urgency for effective diagnostic solutions like the one offered by Co-Diagnostics.
Statement from Co-Diagnostics CEO
CEO Dwight Egan stated, "We have received customer inquiries regarding the performance of the Logix Smart ABC test against this year's influenza strains. 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."
About the Logix Smart ABC Test
Since its CE-marking in November 2020, the Logix Smart ABC test has been recognized for its ability to simultaneously detect and differentiate between influenza A, influenza B, and SARS-CoV-2, the virus responsible for COVID-19. The Co-Primers utilized target a specific area of the MP gene in influenza A, while mutations related to subclade K occur within the HA region. The recent analysis concludes that upcoming strains of H3N2 will not compromise the test's sensitivity.
The Logix Smart ABC test is exclusively designed for qualified and trained clinical laboratory personnel, ensuring precision and reliability in diagnostic testing.
Future Developments at Co-Diagnostics
In November **2025**, Co-Diagnostics announced the commencement of clinical performance testing for its Co-Dx PCR Flu A/B, COVID-19, RSV point-of-care upper-respiratory multiplex test. This initiative is aimed at ensuring submission to the U.S. Food and Drug Administration (FDA) for a 510(k) clearance. Encouragingly, preliminary analyses indicate that flu A targets in this forthcoming test are not expected to be influenced by the H3N2 subclade K either.
It is important to note that the Logix Smart ABC test is currently not approved or cleared by the FDA for sale in the United States and is designated for export only.
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., based in Utah, specializes in developing, manufacturing, and marketing advanced diagnostic technologies. The company’s innovations focus on the detection and analysis of nucleic acid molecules (DNA or RNA), using its proprietary methodologies to establish particular tests for its Co-Dx PCR at-home and point-of-care diagnostics platform.
Forward-Looking Statements
This announcement contains forward-looking statements regarding the anticipated performance and sensitivity of Co-Diagnostics’ testing products. These projections are based on current expectations and are subject to various risks that may cause actual results to differ materially. Such factors include changes in viral genomics, regulatory processes, clinical testing, and market conditions. Investors are encouraged to review details in the Company’s filings with the Securities and Exchange Commission, including the latest Annual Report on Form 10-K.