Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™ PCR Platform to Support Submission to the U.S. FDA

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) has begun clinical evaluations for its Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit on the compact Co-Dx PCR Pro instrument to support a U.S. FDA 510(k) submission. The company said results may also support submissions to other regulators, including the Saudi Food and Drug Authority, and plans an India introduction via joint venture CoSara Diagnostics.

The multiplex RT-PCR test simultaneously detects influenza A, influenza B, COVID-19, and RSV at point-of-care; the Co-Dx PCR platform remains under regulatory review and is not available for sale.

Positive

• Initiated clinical evaluations to support FDA 510(k) submission
• Company expects regulatory submissions beyond the U.S., including Saudi FDA
• Planned India market entry via joint venture CoSara Diagnostics
• Multiplex test detects 4 respiratory pathogens on Co-Dx PCR Pro

Negative

• Co-Dx PCR platform is subject to regulatory review and not for sale
• Commercialization depends on clinical results and regulatory clearance

Insights

Regulatory & Clinical Strategy Analyst

Initiation of clinical evaluations for a multiplex respiratory PCR and an FDA 510(k) pathway is a constructive regulatory milestone for Co-Dx.

The company has begun clinical performance testing for the Co-Dx™ PCR Flu A/B, COVID-19, RSV Test Kit and the Co-Dx PCR Pro™ instrument with the explicit intent to support a U.S. FDA 510(k) submission; this step advances the regulatory dossier from development to clinical evidence generation. The test targets simultaneous detection of influenza A, influenza B, COVID-19, and RSV using reverse-transcriptase PCR on a compact, near‑patient platform, and the program includes planned regulatory submissions beyond the U.S., including the Saudi Food and Drug Authority and market introduction via a joint venture in India (CoSara Diagnostics).

Key dependencies and risks remain: clinical performance results must meet the standards required for a 510(k) clearance, and the platform itself is explicitly "subject to review" and "not available for sale." Regulatory timelines, comparator performance, and study design will determine whether the data support clearance. The announcement does not supply clinical endpoints, sample size, or expected completion dates, so outcome certainty is limited. Watch for release of clinical performance metrics, formal 510(k) filing dates, and any FDA feedback over the next 6–18 months; also monitor filings or approvals with the Saudi regulator and progress of the CoSara joint venture for the Indian market.

SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has begun clinical evaluations for its Co-Dx™ PCR Flu A/B, COVID-19, RSV Test Kit. The clinical performance testing is expected to support a submission to the United States Food and Drug Administration ("FDA") for 510(k) clearance of the upper respiratory multiplex point-of-care test, and the Co-Dx PCR Pro™* instrument.

"We are pleased with the diligent work of our development team in preparing this test to begin this clinical performance testing," remarked Dwight Egan, CEO of Co-Diagnostics. "Regulatory clearance and commercialization of the Co-Dx PCR platform remain the Company's primary objectives, and our research suggests that the market is primed for decentralized, gold-standard PCR testing, especially for respiratory infections. Our platform is designed to meet this growing demand by bringing accurate, reliable testing options to near-patient environments.

"In addition to an FDA submission, we also anticipate that the results of our clinical testing may support submissions to other regulatory bodies, such as the Saudi Food and Drug Authority."

According to a recent Grand View research report, the estimated value of the respiratory infectious disease diagnostics market was $54.58 billion in 2024. Of that, molecular diagnostics accounts for roughly two-thirds of the total value and North America represents the largest geographical market. By 2030, the global market is projected to grow to $73.56 billion, fueled by rising adoption of point-of-care (POC) diagnostics in settings such as physicians' offices, where patient preference for rapid, convenient testing continues to accelerate.

The market for respiratory infectious disease diagnostics in the Middle East is also expanding, largely influenced by substantial investments in the Kingdom of Saudi Arabia (KSA) and its commitment to improving public health in alignment with Saudi Vision 2030 initiatives. Co-Dx intends to introduce the test into the Indian market as well, through joint venture CoSara Diagnostics, along with the platform tests for tuberculosis and HPV that are also nearing commencement of clinical evaluations.

The Co-Dx™ PCR Flu A/B, COVID-19, RSV Test Kit is designed for the simultaneous detection and differentiation of influenza A, influenza B, COVID-19, and RSV on the compact Co-Dx PCR Pro instrument. Using reverse-transcriptase PCR, the device provides decentralized upper respiratory infection test results at the point-of-care or near point-of-care.

*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. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Forward-looking statements include statements made with respect to our Co-Dx PCR platform, including statements about potential or future clinical evaluations, regulatory submissions, and, product performance, market opportunities, or commercialization efforts related to the Co-Dx PCR platform and associated tests. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

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SOURCE Co-Diagnostics

FAQ

What did Co-Diagnostics (CODX) announce on November 18, 2025 regarding FDA filings?

Co-Diagnostics began clinical evaluations for its multiplex respiratory test to support a U.S. FDA 510(k) submission for the Co-Dx PCR Pro platform.

Which pathogens does the Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit detect on CODX's platform?

The test is designed to simultaneously detect and differentiate influenza A, influenza B, COVID-19, and RSV using RT-PCR.

Is the Co-Dx PCR platform (CODX) currently available for sale?

No; the Co-Dx PCR platform is subject to regulatory review by the FDA and other bodies and is not available for sale.

Will CODX seek regulatory approvals outside the U.S. following the clinical evaluations?

Yes; the company anticipates clinical results may support submissions to other regulators, including the Saudi Food and Drug Authority.

Does Co-Diagnostics plan to commercialize the test in India (CODX)?

Co-Diagnostics intends to introduce the test into India through its joint venture CoSara Diagnostics.

How does this clinical program affect CODX's commercialization timeline?

The announcement indicates clinical evaluations are underway to support clearance; actual commercialization remains contingent on clinical results and regulatory decisions.