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
News Market Reaction
On the day this news was published, CODX gained 13.37%, reflecting a significant positive market reaction. Argus tracked a peak move of +16.1% during that session. Our momentum scanner triggered 34 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $23M at that time.
Data tracked by StockTitan Argus on the day of publication.
"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
The market for respiratory infectious disease diagnostics in the
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
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?
Which pathogens does the Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit detect on CODX's platform?
Is the Co-Dx PCR platform (CODX) currently available for sale?
Will CODX seek regulatory approvals outside the U.S. following the clinical evaluations?
Does Co-Diagnostics plan to commercialize the test in India (CODX)?
How does this clinical program affect CODX's commercialization timeline?
