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

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) performed an in silico analysis of the Co-Primers used in its Logix Smart ABC test and reported high homology against 3,900 influenza sequences, finding comparable reactivity to influenza A H3N2 subclade K (J.2.4.1).

The company noted the Logix Smart ABC test targets the MP gene while subclade K mutations occur in the HA region, and concluded no concern for reduced test sensitivity. The Logix Smart ABC test holds CE marking (November 2020) and is export-only. In November 2025 Co-Dx began clinical performance testing for a POC multiplex test intended to support a 510(k) submission to the FDA.

Positive

• In silico homology confirmed against 3,900 influenza sequences
• Logix Smart ABC targets MP gene, distant from subclade K HA mutations
• Initiated clinical performance testing for POC Flu A/B, COVID-19, RSV multiplex to support 510(k)

Negative

• Logix Smart ABC test is not FDA cleared and is for export only
• Co-Dx PCR platform is subject to FDA review and is not available for sale in the U.S.

Key Figures

Sequence count 3,900 influenza sequences In silico analysis for Logix Smart ABC test

Severe flu cases 3–5 million Annual global seasonal influenza severe illnesses (WHO)

Flu fatalities 290,000–650,000 Annual global respiratory deaths from seasonal influenza (WHO)

Technology duration more than five years Time since Logix Smart ABC test development

CE-marking date November 2020 Logix Smart ABC test CE-marking for influenza A/B and SARS-CoV-2

FDA pathway 510(k) Planned submission for Co-Dx PCR Flu A/B, COVID-19, RSV test

November 2025 update clinical performance testing initiated Co-Dx PCR Flu A/B, COVID-19, RSV point-of-care test

Market Reality Check

$0.2759 Last Close

Volume Volume 2,776,834 is 1.57x the 20-day average of 1,763,685, indicating elevated trading activity. high

Technical Price 0.2461 is trading below the 200-day MA at 0.35, reflecting a weak longer-term trend.

Peers on Argus 1 Up

CODX fell 8.89% while peer XAIR appeared in momentum scanners, moving 6.440000236034393% up without same-day news linkage, suggesting stock-specific factors for CODX.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 09	Conference presentation	Positive	+4.5%	Presentation on Co-Dx PCR platform and AI integration at PoC conference.
Dec 08	JV conference activity	Neutral	-7.4%	CoSara JV presence at VIROCON and preclinical MTB/HPV study updates.
Nov 20	TB test strategy	Positive	-5.8%	Address on MTB test adoption and potential CoSara SPAC transaction.
Nov 18	Clinical evaluations start	Positive	+13.4%	Initiation of clinical evaluations for upper respiratory multiplex PoC test.
Nov 13	Q3 2025 earnings	Negative	-6.1%	Q3 revenue drop, continued losses, financings and going-concern disclosure.

Pattern Detected

CODX often reacts sharply to news, with generally aligned moves; positive R&D or platform updates have triggered both rallies and sell-offs, while negative earnings news aligned with downside.

Recent Company History

Over the last month, CODX has highlighted its Co-Dx PCR platform across multiple contexts. On Nov 13, Q3 2025 results showed minimal revenue and ongoing losses alongside new financings, and the stock fell 6.11%. Subsequent news on initiating clinical evaluations for an upper-respiratory multiplex test on Nov 18 saw a 13.37% gain. Additional updates on tuberculosis testing, India expansion plans, and conference presentations in late November and early December produced mixed reactions. Today’s influenza in silico analysis fits the pattern of frequent technical updates around the platform.

Market Pulse Summary

The stock moved +6.5% in the session following this news. A strong positive reaction aligns with CODX’s history of sharp moves on technical and regulatory updates, such as the 13.37% gain after initiating clinical evaluations on Nov 18, 2025. However, prior rallies sometimes faded quickly amid ongoing losses and going‑concern disclosures from recent filings. Investors reviewing such a move typically weighed regulatory timelines, commercialization status, and capital needs highlighted in past reports when assessing how durable any strength might be.

Key Terms

in silico technical

"announced that it has performed an in silico analysis of the Co-Primers"

In silico means using computer models, simulations, or data analysis to study biological, chemical, or financial processes instead of physical experiments. For investors, in silico work can speed up research, lower costs and highlight promising opportunities or risks early—like using a flight simulator to test maneuvers before flying a real plane—while still requiring real-world testing to confirm results.

co-primers technical

"analysis of the Co-Primers used in its Logix Smart ABC test"

Co-primers are two short DNA pieces used together to start and control copying of a specific genetic target in laboratory tests; one binds next to the other so the copying enzyme begins at the correct spot. For investors, co-primers matter because they can make diagnostic tests more accurate and faster—like using a keyed pair instead of a single key to reduce false alarms—affecting a test’s clinical reliability, regulatory approval, and market competitiveness.

ce-marking regulatory

"In November 2020, the Logix Smart ABC test received CE-marking"

CE marking is an official label placed on products to show they meet European Union safety, health and environmental rules required to sell in the European Economic Area. For investors, it matters because it determines market access and can affect sales, regulatory costs and liability — think of it as a passport or safety sticker that lets a product enter and compete in a large market.

sars-cov-2 medical

"influenza B, and SARS-CoV-2, the virus that causes COVID-19."

SARS-CoV-2 is the virus that causes the illness known as COVID-19; think of it as a biological engine that can start chains of sickness in people. It matters to investors because its spread and the measures taken to control it—such as changes to workforce availability, consumer demand, supply chains, travel, and healthcare spending—can quickly alter company revenues, costs and regulatory priorities, much like a sudden storm that affects many parts of an economy at once.

pcr technical

"access to high-quality PCR testing solutions."

PCR (polymerase chain reaction) is a laboratory method that makes many copies of a tiny piece of genetic material (DNA or RNA) so scientists can detect and study it reliably — think of photocopying a faint, tiny note until the words are easy to read. For investors, PCR matters because it underpins diagnostic tests, drug development, and biotech tools whose sales, regulatory approvals, and real-world use can materially affect company revenues and market perceptions during health events or product launches.

510(k) clearance regulatory

"intended to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance."

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

AI-generated analysis. Not financial advice.

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.

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SOURCE Co-Diagnostics

FAQ

Does Co-Diagnostics' Logix Smart ABC test detect influenza A H3N2 subclade K (J.2.4.1)?

The company reports an in silico analysis showing high homology and comparable reactivity against H3N2 subclade K.

How many influenza sequences were included in Co-Diagnostics' analysis for CODX?

The analysis evaluated homology against 3,900 influenza sequences.

Has the Logix Smart ABC test received FDA clearance for use in the U.S. (CODX)?

No; the Logix Smart ABC test is not approved or cleared by the FDA and is for export only.

What gene does the Logix Smart ABC test target vs. where subclade K mutations occur (CODX)?

The test's Co-Primers target the MP gene, while subclade K mutations are in the HA region.

What regulatory steps is Co-Diagnostics taking for its POC multiplex test (CODX)?

In November 2025 the company began clinical performance testing to support a planned 510(k) submission to the FDA.

Will the reported in silico results change availability of Co-Diagnostics tests in the U.S. (CODX)?

The company states the Logix Smart ABC test retains sensitivity, but the test remains export only and not for U.S. sale.