Co-Diagnostics' Joint Venture CoSara Diagnostics Completes Clinical Study and Regulatory Submission for Point-of-Care Tuberculosis Test, Sets Stage for Commercial Launch in India

The study's comparative results were based on 233 paired samples, with regulatory clearance still required before sales.

Rhea-AI Summary

Co-Diagnostics (CODX) announced that its Indian joint venture, CoSara Diagnostics, completed a tuberculosis test clinical study and submitted it for regulatory clearance. The study assessed 676 clinical samples, including 233 paired with MGIT testing that formed the comparative performance results. Across three batches, average sensitivity was 97.3%, measuring detection of TB-positive samples, and average specificity was 96.0%, measuring identification of negative samples.

The application is under review by India's Central Drugs Standard Control Organization, which may impose additional requirements. Co-Diagnostics and CoSara expect approval in Q4 2026, positioning CoSara to begin Indian commercial sales before year-end. Mobile and cloud infrastructure has been deployed in India to support the anticipated launch. Sales remain dependent on regulatory clearance.

6 points · 0 major

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointClinical study completed and CDSCO submission made for CoSara's point-of-care tuberculosis test.
• Moderate point97.3% average sensitivity and 96.0% average specificity demonstrated across three test batches, with consistent performance.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Q4 2026 approval expected by Co-Diagnostics and CoSara, positioning Indian commercial sales to begin before year-end.
• Moderate pointFDA 510(k) submission made in August for the company's platform.
• Minor pointMobile and cloud infrastructure deployed in India to support the anticipated commercial launch.
• Minor point. Forward-looking: it has not happened yet and may not happen.Sales activities planned across India and parts of South Asia upon CDSCO clearance.

Negative

• Moderate pointCDSCO review remains pending, with potential additional regulatory requirements and sales dependent on clearance.
• Moderate pointFDA submission remains under review; the Co-Dx PCR platform is not yet available for sale.

Argus 15 min delay 7 alerts

-3.16% vs previous close $0.53 last price 187.1x rel. volume Open Argus

Details

Market move: CODX -3.16% vs previous close. TB clinical data

$0.51 – $0.65 Day Range

$3.69M Mkt Cap at Last Price

On Oct 27, the day this news came out, the latest delayed price for CODX is 3.16% below the previous close. Our momentum scanner has recorded 7 alerts for this stock so far that day. The latest delayed price is $0.53. Relative volume is exceptionally heavy at 187.1x the average.

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Key Figures

Clinical samples assessed: 676 samples Samples paired with MGIT: 233 samples Average sensitivity: 97.3% +3 more

Clinical samples assessed

676 samples

CoSara PCR MTB clinical study

Samples paired with MGIT

233 samples

Formed the basis of reported comparative performance results

Average sensitivity

97.3%

Against the TB detection reference standard

Average specificity

96.0%

Against the TB detection reference standard

Test batches evaluated

3 batches

Study reported consistent performance across batches

Expected regulatory approval

Q4 2026

Company and CoSara expectation; application is under CDSCO review

Previous Partnership,clinical trial Reports

1 past event · Latest: Jul 22

Same Type 1 event

1. Jul 22

   Clinical study initiation

   24h Move

   -3.4%

   CoSara initiated India clinical studies for the same tuberculosis test, preceding completed study results.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

real-time pcr, 510(k)

2 terms

real-time pcr technical

"deliver rapid real-time PCR results in roughly 30 minutes via a mobile application"

Real-time PCR is a laboratory method that copies and measures specific genetic material (DNA or RNA) as the reaction happens, giving immediate numerical results rather than only an end-point yes/no. For investors, it matters because it underpins fast, sensitive medical tests and research tools; performance, regulatory acceptance, and manufacturing capacity for real-time PCR systems can directly affect demand, revenue potential, and competitive position in the diagnostics and biotech markets.

510(k) regulatory

"Together with our FDA 510(k) submission in August"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CDSCO Clearance and Commercial Launch in India Anticipated Before Year-End 2026

Study Demonstrated 97.3% Sensitivity and 96.0% Specificity
Consistent Performance Across Three Test Batches

Integrated Mobile and Cloud Infrastructure Already Deployed in India to Support Anticipated
Commercial Launch

SALT LAKE CITY, Oct. 27, 2026 /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 Company's joint venture in India, has completed its clinical performance study of the CoSara PCR Mycobacterium tuberculosis ("MTB" or "TB") test on the CoSara PCR Pro^® instrument* and has submitted the test to India's Central Drugs Standard Control Organization ("CDSCO") for regulatory clearance.

The submission follows the Company's July 22, 2026 announcement that CoSara had initiated clinical studies for the CoSara PCR MTB test across select laboratories in India. The clinical study assessed 676 clinical samples, including 233 paired with MGIT testing that formed the basis of the reported comparative performance results. The evaluation represents an important milestone supporting CoSara's CDSCO submission and advancing the CoSara PCR MTB test toward potential commercial launch in India.

The clinical evaluation was conducted in India in accordance with the applicable study requirements and resulting documentation forms part of the regulatory submission. The application is now subject to review by CDSCO, including any additional requirements that may arise during the regulatory process. Across three test batches evaluated during the clinical study, the CoSara PCR MTB test demonstrated an average sensitivity of 97.3% and an average specificity of 96.0% against the reference standard for TB detection, with highly consistent performance across batches.

India accounts for approximately one quarter of the world's tuberculosis cases, the highest burden of any country, according to the World Health Organization's Global Tuberculosis Report 2025, making it one of the most strategically important markets for the Company's mission of closing critical gaps in access to high-quality PCR testing. The CoSara PCR Pro instrument, the CoSara-branded version of the Co-Dx™ PCR Pro point-of-care instrument, leverages the Company's patented Co-Primers^® technology to deliver rapid real-time PCR results in roughly 30 minutes via a mobile application, without the need for centralized laboratory infrastructure.

Supporting the platform's anticipated commercial launch, Co-Dx has also deployed its integrated mobile and cloud infrastructure in India, establishing a localized system for test analysis and secure data management. The architecture enables the platform's mobile application to generate test results in decentralized settings without continuous internet connectivity, with test data synchronized to the cloud when connectivity is restored.

"Completing this clinical study and submitting to the CDSCO is a defining milestone for our India program and a significant execution achievement for Co-Diagnostics," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Since forming CoSara in 2017, we have invested in building the manufacturing, regulatory and commercial infrastructure needed to bring affordable, decentralized molecular TB testing to the country with the largest tuberculosis burden in the world. With our integrated mobile and cloud infrastructure now deployed in India, we have also established the digital foundation needed to support testing, secure data management and future commercial operations across decentralized healthcare settings."

Mr. Egan continued, "We are extremely pleased with the results of this study. The strength and consistency of the test's clinical performance reflects both the capabilities of our Co-Primers^® technology and the readiness of CoSara's manufacturing operations as we prepare for launch. Our team has spent more than three years preparing to bring this test to market, and with this submission complete, we are entering the next phase of our India strategy and are positioned to move quickly from regulatory review to commercial launch, which we expect to begin in India before the end of this year. Together with our FDA 510(k) submission in August, we now have two major regulatory submissions under review in two of the most important markets for our platform." 

The Company and CoSara currently expect regulatory approval of the CoSara PCR MTB test in the fourth quarter of 2026, which would position CoSara to begin commercial sales of the test in India before year-end. CoSara has been actively preparing for the commercial launch of the test through extensive planning and market development efforts, positioning the joint venture to move quickly upon regulatory clearance. Upon receipt of CDSCO clearance, CoSara plans to initiate sales activities across India and parts of South Asia, supported by CoSara's direct sales team, distributors, product demonstrations and customer outreach in targeted markets. 

*The Co-Dx PCR platform (including the PCR Home^®, PCR Pro^®, mobile app, and all associated tests) is subject to review or authorization by applicable regulatory authorities in the jurisdictions in which clearance or approval is sought, including the US FDA, 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 using the detection and/or analysis of 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.

About CoSara Diagnostics Private Limited:
CoSara Diagnostics Private Limited is an India-based molecular diagnostics company formed as a joint venture between Co-Diagnostics, Inc. and Synbiotics Ltd, a subsidiary of Ambalal Sarabhai Enterprises Ltd. (ASE Group), a continuation of one of the oldest and most respected Indian manufacturing institutions in operation today. CoSara was established in 2017 to manufacture and commercialize molecular diagnostic instruments and assays in India, leveraging Co-Diagnostics' proprietary PCR technology platform while operating under applicable Indian regulatory frameworks. The company is focused on expanding access to high-quality, affordable PCR-based diagnostic solutions for use in India and other permitted markets.

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing, substance and outcome of CDSCO's review of the CoSara PCR MTB test and CoSara PCR Pro instrument, including the Company's expectation of clearance in the fourth quarter of 2026 and the anticipated commencement of commercial sales in India before year-end; the Company's and CoSara's go-to-market and commercialization plans and timing in India and other markets in South Asia, including launch preparation, direct sales, distribution, product demonstration and customer outreach activities; and the Company's expectations regarding the Co-Dx PCR platform's role in expanding access to tuberculosis testing. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that market demand or public health conditions may change; risks related to the Company's or CoSara's ability to obtain CDSCO clearance on the timeline anticipated, or at all; risks that the CDSCO may request additional information, testing or data, delay its review, or decline to grant clearance; risks related to the Company's or CoSara's ability to commercialize the platform in a strategically important market, including risks that distribution partners may not successfully market, promote, or sell the Company's products; risks associated with international operations, including changing regulatory requirements, economic conditions, reimbursement environments, import/export restrictions, and foreign currency fluctuations; risks related to regulatory review by regulatory authorities that would be required to achieve a successful commercial launch; risks that performance observed in clinical studies or laboratory evaluations may not be replicated in broader clinical use or with other sample types; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technologies; risks associated with dependence on third parties, suppliers, collaborators, and distribution partners; risks related to competition, technological change, and intellectual property protection; and other risks described from time to time in the Company's filings with the Securities and Exchange Commission ("SEC"). Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

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SOURCE Co-Diagnostics

FAQ

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What did Co-Diagnostics' CoSara tuberculosis test clinical study show?

The test demonstrated 97.3% average sensitivity and 96.0% average specificity against the reference standard across three test batches. The study assessed 676 clinical samples; 233 paired with MGIT testing formed the basis of the comparative performance results.

When does Co-Diagnostics expect CoSara's tuberculosis test to launch in India?

Co-Diagnostics and CoSara expect regulatory approval in the fourth quarter of 2026, positioning CoSara to begin commercial sales in India before year-end. The application remains under CDSCO review, and commercial sales depend on regulatory clearance.

How does CoSara plan to sell its tuberculosis test after regulatory clearance?

CoSara plans to initiate sales activities across India and parts of South Asia after CDSCO clearance. Its planned approach uses a direct sales team, distributors, product demonstrations and customer outreach in targeted markets.