Co-Diagnostics JV, CoSara, to Participate at VIROCON 2025 in Pune, India
Rhea-AI Summary
Co-Diagnostics (Nasdaq: CODX) announced that its JV CoSara will host a booth at VIROCON 2025 (Dec 8-10, 2025) in Pune, India and is supporting Phase II preclinical studies for Co-Dx PCR MTB (tuberculosis) and Co-Dx PCR HPV multiplex tests on the Co-Dx PCR point-of-care platform.
Key study counts: MTB Phase I used 354 clinical specimens; MTB Phase II evaluated 211 sputum specimens for concordance; HPV Phase I evaluated 286 specimens; HPV Phase II has analyzed 53 specimens to date. The company says preclinical data support advancing to clinical performance testing required by Indian regulators. The Co-Dx PCR platform remains under FDA/other regulatory review and is not yet for sale.
Positive
- MTB Phase I tested 354 clinical specimens
- MTB Phase II evaluated 211 sputum specimens
- HPV Phase I validated with 286 clinical specimens
- Company states data support advancement to clinical testing
Negative
- HPV Phase II has only 53 specimens analyzed so far
- Co-Dx PCR platform is not yet available for sale pending reviews
Key Figures
Market Reality Check
Peers on Argus
Peers showed mixed moves, with names like INBS (-3.39%), XAIR (-11.54%), and AIMD (-5.16%) down while SINT (+4.4%) was up, indicating today’s CODX weakness is more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 20 | TB test conference update | Positive | -5.8% | Highlighted MTB test adoption plans and possible SPAC for CoSara. |
| Nov 18 | Clinical evaluations start | Positive | +13.4% | Initiated clinical evaluations for upper respiratory multiplex PoC test. |
| Nov 13 | Q3 2025 earnings | Negative | -6.1% | Reported sharp revenue decline, continued losses, and small revenue base. |
| Nov 12 | Saudi JV recognition | Positive | +0.7% | Utah leaders recognized new CoMira JV and MENA expansion. |
| Nov 05 | SPAC advisor engaged | Positive | +3.5% | Hired Maxim Group to explore SPAC or similar listing for CoSara. |
CODX’s stock has generally moved in the same direction as the perceived tone of prior news, with one recent instance of a selloff following seemingly positive tuberculosis-related messaging.
This announcement builds on a series of updates around the Co-Dx PCR platform and global joint ventures. In November 2025, CODX advanced clinical evaluations for an upper-respiratory multiplex PoC test and discussed upcoming MTB testing and SPAC options for CoSara, while also reporting weak Q3 results and ongoing losses. The company was recognized for its Saudi JV and engaged Maxim Group to explore a SPAC listing for CoSara. Today’s preclinical MTB and HPV data and CoSara’s presence at VIROCON 2025 continue that narrative of platform and JV development.
Market Pulse Summary
This announcement highlights advancing Phase I and II preclinical data for Co-Dx PCR MTB and HPV tests, with 354 and 211 MTB specimens and 286 and 53 HPV specimens evaluated so far. CoSara’s booth at VIROCON 2025 underscores the joint venture’s role in India-focused deployment. Investors may track progression into clinical performance testing, regulatory submissions in India and elsewhere, and how these assays complement prior respiratory multiplex work and SPAC discussions tied to CoSara.
Key Terms
preclinical medical
AI-generated analysis. Not financial advice.
Ongoing Phase II preclinical study data for Co-Dx PCR MTB and HPV tests support advancement to clinical performance testing
CoSara is currently supporting the second phase of the Company's preclinical studies for the Co-Dx PCR MTB (tuberculosis) test and Co-Dx PCR HPV multiplex test on the Co-Dx PCR point-of-care (PoC) platform*. Phase I of the MTB test studies included 354 clinical specimens from sputum and tongue swabs to provide early sensitivity and specificity assessments, while Phase II has evaluated 211 sputum specimens in a comparison evaluation against other tests to establish concordance for Mycobacterium tuberculosis detection. The studies are being conducted in preparation of advancement to clinical performance testing, required by Indian regulatory authorities prior to submission.
Phase I of the preclinical studies for the 8-type HPV multiplex test, designed to identify the presence of eight different human papillomavirus genotypes, evaluated 286 clinical specimens to validate and optimize the Co-Primers® test chemistry for HPV. Three of the eight genotypes are classified as high-risk for cancer, and in Phase II, 53 specimens have been analyzed to date to facilitate the differential detection of the three high-risk HPV genotypes as the application algorithm continues to be trained, refined and optimized.
The Company believes that data gathered thus far in the preclinical studies for both tests support advancement to clinical performance testing, as part of the pathway to regulatory submissions.
Attendees interested in learning more about CoSara products, including the TB and HPV tests on the Company's upcoming Co-Dx PCR platform, are encouraged to stop by at VIROCON 2025. CoSara will be available for meetings and interactions at CoSara's booth.
VIROCON 2025 is organized by the India Council of Medical Research - National Institute of Virology ("ICMR-NIV"), with this year's theme being "Changing Landscape in Human, Animal, and Plant Viruses: Bridging Basic Science, Innovations and Public Health." The conference is expected to provide a platform for productive scientific deliberations and collaborations aimed at developing solutions to contain the viral epidemics that threaten human, animal, plant, aquatic and environmental health.
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet 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 and tests, including statements about potential or future clinical performance studies, regulatory submissions, 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 at VIROCON 2025 on Dec 8-10, 2025?
How many specimens were used in Co-Dx MTB Phase I and Phase II preclinical studies?
What are the specimen counts for the Co-Dx HPV preclinical studies reported by CODX?
Does Co-Diagnostics say the preclinical data are sufficient for regulatory steps for CODX tests in India?
Is the Co-Dx PCR platform available for sale now for CODX investors?
