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

News Market Reaction

-7.37%

6 alerts

-7.37% News Effect

-3.1% Trough in 49 min

-$2M Valuation Impact

$21M Market Cap

0.5x Rel. Volume

On the day this news was published, CODX declined 7.37%, reflecting a notable negative market reaction. Argus tracked a trough of -3.1% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $21M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MTB Phase I specimens: 354 clinical specimens MTB Phase II specimens: 211 sputum specimens HPV Phase I specimens: 286 clinical specimens +4 more

7 metrics

MTB Phase I specimens 354 clinical specimens Phase I preclinical study for Co-Dx PCR MTB test

MTB Phase II specimens 211 sputum specimens Phase II comparison evaluation for MTB detection

HPV Phase I specimens 286 clinical specimens Phase I preclinical study for 8-type HPV multiplex test

HPV Phase II specimens 53 specimens Phase II analysis for high-risk HPV genotype detection

HPV genotypes covered 8 genotypes HPV multiplex test detects eight HPV genotypes

High-risk HPV genotypes 3 high-risk genotypes Subset of eight HPV genotypes classified as high-risk for cancer

VIROCON 2025 dates December 8–10, 2025 Conference in Pune, India featuring CoSara booth

Market Reality Check

Price: $2.35 Vol: Volume 823,410 versus 20-...

low vol

$2.35 Last Close

Volume Volume 823,410 versus 20-day average 1,788,884 suggests lighter-than-normal trading ahead of this update. low

Technical Shares at $0.3745 are trading above the 200-day moving average of $0.35 despite a large discount to the $1.55 52-week high.

Peers on Argus

Peers showed mixed moves, with names like INBS (-3.39%), XAIR (-11.54%), and AIM...

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.

Common Catalyst Both CODX and peer SINT highlighted participation in industry conferences, suggesting investor focus on visibility and partnership opportunities rather than broad device-sector news.

Historical Context

5 past events · Latest: Nov 20 (Positive)

Pattern 5 events

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.

Pattern Detected

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.

Recent Company History

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

The stock moved -7.4% in the session following this news. A negative reaction despite constructive p...

Analysis

The stock moved -7.4% in the session following this news. A negative reaction despite constructive preclinical data would fit prior instances where CODX sold off around seemingly positive tuberculosis-related updates. The stock has been trading far below its 52-week high and faces overhangs from recent losses, financing activity, and reverse-split authorization. In that context, investors may have focused more on balance sheet and listing risks than on incremental progress, raising the possibility of overshooting to the downside if execution improves.

Key Terms

preclinical, phase ii, pcr, point-of-care (poc), +4 more

8 terms

preclinical medical

"CoSara is currently supporting the second phase of the Company's preclinical studies"

Preclinical describes the stage of drug or medical-product development when researchers test a candidate in the lab and in animals to see if it is safe, reaches intended targets, and shows basic effectiveness before any human trials begin. For investors, preclinical status signals an early, higher‑risk opportunity where positive lab results can increase value but significant work, time, and regulatory hurdles remain — like proofing a prototype in a workshop before road testing.

phase ii medical

"Phase II has evaluated 211 sputum specimens in a comparison evaluation"

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

pcr medical

"the Co-Dx PCR MTB (tuberculosis) test and Co-Dx PCR HPV multiplex test"

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.

point-of-care (poc) medical

"on the Co-Dx PCR point-of-care (PoC) platform*"

Point-of-care (POC) describes medical tests, treatments, or devices used at the place and time a patient receives care — for example, a rapid blood test done at a clinic, pharmacy, or bedside rather than in a distant lab. Investors care because POC products can speed diagnosis and treatment, often lowering costs and expanding market reach; like a compact coffee maker versus a factory roast, convenience can drive higher demand and faster revenue recognition.

multiplex medical

"Co-Dx PCR HPV multiplex test on the Co-Dx PCR point-of-care (PoC) platform"

A multiplex is a laboratory test or diagnostic method that detects or measures several different targets at the same time from a single sample, like checking for multiple ingredients in one recipe rather than cooking separate dishes. For investors, multiplex technologies can lower testing costs, speed results, and expand market reach because one product can serve multiple purposes, affecting revenue potential, production scale, and regulatory review paths.

mycobacterium tuberculosis medical

"to establish concordance for Mycobacterium tuberculosis detection"

Mycobacterium tuberculosis is the bacterium that causes tuberculosis (TB), a contagious lung infection that can become chronic and hard to treat. Think of it as a stubborn weed that can survive in the body and, in some cases, resist standard treatments; this matters to investors because the threat of drug-resistant strains, new diagnostics, vaccines, or treatments can drive demand, regulatory scrutiny, public health spending, and the commercial prospects of healthcare companies.

human papillomavirus medical

"designed to identify the presence of eight different human papillomavirus genotypes"

Human papillomavirus (HPV) is a family of common viruses that infect the skin and mucous membranes; some types cause harmless warts while others can lead to cancers. For investors, HPV matters because demand for diagnostics, vaccines and treatments, plus results from clinical trials, regulatory approvals and public health screening programs, directly affects the revenue and risk profile of companies working in vaccines, diagnostics and related healthcare markets — like different models of a product with different market impacts.

fda regulatory

"subject to review by the FDA and/or other regulatory bodies"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

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

SALT LAKE CITY, Dec. 9, 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 CoSara Diagnostics Pvt. Ltd. ("CoSara"), the joint venture ("JV") between Ambalal Sarabhai Enterprises Limited (ASE Group) and Co-Dx, will participate and host a booth at VIROCON 2025, taking place December 8-10 at the Conrad Hotel in Pune, Maharashtra, India.

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 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 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?

CoSara will host a booth at VIROCON 2025 and is supporting Phase II preclinical studies for Co-Dx PCR MTB and HPV tests.

How many specimens were used in Co-Dx MTB Phase I and Phase II preclinical studies?

MTB Phase I used 354 clinical specimens; MTB Phase II evaluated 211 sputum specimens for concordance.

What are the specimen counts for the Co-Dx HPV preclinical studies reported by CODX?

HPV Phase I evaluated 286 specimens; HPV Phase II has analyzed 53 specimens to date.

Does Co-Diagnostics say the preclinical data are sufficient for regulatory steps for CODX tests in India?

The company says the preclinical data support advancement to clinical performance testing required by Indian regulatory authorities.

Is the Co-Dx PCR platform available for sale now for CODX investors?

No; the Co-Dx PCR platform is under FDA and/or other regulatory review and is not yet available for sale.