Co-Diagnostics Ships Diagnostic Materials to India for Initiation of Tuberculosis Clinical Studies Following Recently Issued Guidance from the World Health Organization

Rhea-AI Summary

Co-Diagnostics (Nasdaq: CODX) has shipped PCR Pro instruments, Co-Dx PCR MTB test kits and sample-prep devices to joint venture CoSara in India to enable clinical performance studies for a TB test aligned with new WHO 2026 guidance on near-point-of-care molecular testing and tongue swabs. The company also received a CDSCO license to manufacture and sell the PCR Pro instrument in India and says clinical study commencement is expected in the near term while U.S. regulatory review remains ongoing.

Positive

• Shipments of PCR Pro, MTB test kits, and sample-prep instruments to India have commenced
• CDSCO license granted to manufacture and sell the PCR Pro instrument in India
• Test design aligns with WHO near-point-of-care and tongue-swab recommendations

Negative

• Clinical performance studies have not yet started; only final steps remain
• PCR platform and tests remain subject to FDA and other regulatory review and are not yet available for sale
• Timing and outcome of Indian regulatory clearance remain uncertain despite CDSCO license

Argus Mar 25 session

-13.22% close to close Open Argus

Details

News Market Reaction – CODX

On Mar 25, the day this news came out, CODX closed 13.22% below the previous close.

Data tracked by StockTitan Argus for the Mar 25 session.

Market Context

On Mar 25, the day this news came out, the stock closed 13.2% below the previous close. A negative r...

Analysis

On Mar 25, the day this news came out, the stock closed 13.2% below the previous close. A negative reaction despite operational progress would fit a pattern where positive or neutral updates, including patent news and territory expansion, preceded declines of up to -18.83%. The TB clinical study initiation and alignment with WHO guidance mark strategic steps, but prior trading showed weakness following similar milestones. Such behavior could reflect sensitivity to execution risk and past volatility rather than the specifics of this announcement alone.

Key Figures

Global TB incidence reduction: 12% WHO End TB target: 50% reduction India TB incidence reduction: 21% +4 more

Global TB incidence reduction

12%

Change since 2015 per WHO 2025 Global tuberculosis report

WHO End TB target

50% reduction

Target reduction rate vs 2015 per WHO strategy

India TB incidence reduction

21%

Reduction since 2015 in India per 2025 WHO report

India share of cases

25%

Approximate share of global TB cases attributed to India

Cash and cash equivalents

$11.9 million

Preliminary estimate as of Dec 31, 2025 (8-K on Mar 10, 2026)

Common shares outstanding

60,892,582 shares

As of Nov 11, 2025 per 10-Q referenced in Schedule 13G/A

Ayrton Capital ownership

0 shares (0%)

Reported in Schedule 13G/A filed Feb 11, 2026

Historical Context

5 past events · Latest: Mar 20

5 events

1. Mar 20

   Territory expansion

   24h Move

   -2.3%

   Expanded CoSara commercial territory across South Asia for PCR Pro and tests.

2. Mar 17

   Earnings date set

   24h Move

   -8.4%

   Announced Q4 and full-year 2025 earnings release date and webcast details.

3. Mar 16

   Conference participation

   24h Move

   -10.0%

   Planned presentation of Co-Dx PCR platform at Medical Korea 2026 event.

4. Mar 12

   Patent granted

   24h Move

   -18.8%

   Japan patent with 34 claims covering Co-Dx PCR Pro and platform tech.

5. Mar 10

   Nasdaq compliance

   24h Move

   +101.8%

   Regained compliance with Nasdaq listing rules, including $1.00 bid price.

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

Key Terms

near-point-of-care, molecular diagnostics, tongue swab, sputum, +3 more

7 terms

near-point-of-care medical

"WHO tuberculosis recommendations for near-point-of-care molecular testing..."

Near-point-of-care describes medical tests or devices placed close to where patients receive care — for example in clinics, urgent care centers, pharmacies, or outpatient suites — rather than in a distant central laboratory or at the bedside. Like having a coffee machine in the office instead of sending everyone to a café, these tools deliver faster results and simpler workflows, which can speed diagnosis, lower costs, and influence adoption, reimbursement, and revenue potential that investors track.

molecular diagnostics medical

"a molecular diagnostics company with a unique, patented platform..."

Molecular diagnostics are laboratory tests that look for specific molecules — such as genes, pieces of DNA or RNA, or proteins — to detect disease, predict risk, or guide treatment choices. For investors, these tests matter because they can change how illnesses are diagnosed and treated, create recurring revenue through specialized tests and companion products, and face clear regulatory and reimbursement pathways that drive commercial value; think of them as reading a biological barcode to inform medical decisions.

tongue swab medical

"easy-to-collect tongue swabs for patients who cannot produce sputum..."

A tongue swab is a simple, non‑invasive method of collecting saliva and cells by rubbing a sterile swab across the surface of the tongue to test for pathogens, genetic material, biomarkers or drugs. For investors, tongue‑swab tests matter because they can enable cheaper, faster and more convenient diagnostic products that may reach more consumers, affect regulatory clearance paths, and influence market demand, manufacturing scale and reimbursement dynamics — similar to how at‑home pregnancy tests expanded access to a clinical service.

sputum medical

"patients who cannot produce sputum samples, in order to expand access..."

Sputum is the mucus and material coughed up from the lungs and airways, collected as a sample for laboratory testing. For investors, sputum matters because it is a primary clinical specimen used to diagnose respiratory infections, measure drug or vaccine effectiveness, and support regulatory evidence; the ease of collecting reliable sputum samples can affect trial outcomes, market acceptance of diagnostics and therapies, and commercial potential in respiratory health.

clinical performance studies medical

"necessary to begin clinical performance studies of the TB test on the PCR platform..."

Clinical performance studies are organized tests that measure how a medical product, device, test, or treatment works in real patients and real care settings, focusing on safety, accuracy and whether it delivers the expected health benefits. Investors watch these studies because their results influence regulatory approval, market access and sales potential — like a road test that shows whether a new car is safe and reliable before dealers and buyers commit.

cdsco regulatory

"PCR Pro instrument received a license from the CDSCO to be manufactured..."

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority that approves medicines, vaccines, medical devices and sets safety standards for clinical trials and manufacturing. Investors care because CDSCO decisions determine whether health products can be sold, how quickly they reach market, and what safety rules companies must follow — much like a building inspector whose sign-off lets a project open to the public and affects its commercial value.

pcr medical

"Co-Dx PCR MTB test kits* for tuberculosis ("TB")..."

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.

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

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The near-term commencement of clinical studies is expected to align with recent WHO tuberculosis recommendations for near-point-of-care molecular testing and utilizing tongue swab samples

New recommendations are aligned with the design of Co-Dx's proprietary test, platform, and mission

SALT LAKE CITY, March 25, 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 it has commenced shipments of PCR Pro^® instruments*, Co-Dx™ PCR MTB test kits* for tuberculosis ("TB"), and proprietary sample preparation instruments to its joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara") in India. These materials are necessary to begin clinical performance studies of the TB test on the PCR platform, as the Company completes final steps toward initiating those studies in the near term.

According to the World Health Organization's ("WHO") 2025 Global tuberculosis report, the global TB incidence rate was only reduced by 12% since 2015, compared to the WHO's End TB Strategy target reduction rate of 50%. On March 9, the WHO issued recommendations for the first time on near-point-of-care ("NPOC") molecular diagnostics and easy-to-collect tongue swabs for patients who cannot produce sputum samples, in order to expand access to TB testing and help close critical diagnostic gaps.

The Company's PCR testing platform* and NPOC TB test kit are already aligned with this new guidance.

Co-Diagnostics CEO Dwight Egan remarked, "We are pleased that our foresight in designing the Co-Dx PCR testing platform and TB test for broad accessibility in point-of-care and near-point-of-care settings, and to be operated with either sputum or tongue swab samples, is consistent with the direction of the WHO's recommendation. The WHO's recommendation underscores the importance of these technological advances in molecular diagnostics to ensure early and accurate TB testing. Co-Diagnostics' mission to develop and increase access to life-saving PCR tests is aligned to fulfill that objective."

Despite achieving a 21% reduction in TB incidence since 2015, India continues to account for approximately 25% of global cases according to the 2025 Global tuberculosis report.

Mr. Egan continued, "The Co-Dx PCR MTB test has continued to generate encouraging third-party preclinical results, supporting further clinical evaluation. We recently announced that the PCR Pro^® instrument received a license from the CDSCO to be manufactured and sold as a medical device instrument, and expect to announce the commencement of clinical performance studies in India in the near future as we prepare for a submission to the Indian regulatory authorities for clearance."

*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 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.

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 expected benefits of the WHO's recommendation for NPOC TB tests and tongue swab sample types; the expected timing and initiation of clinical performance studies; the Company's plans to pursue regulatory submissions and potential clearances in India and other jurisdictions; the anticipated performance and potential clinical utility of the Company's PCR platform and TB test; and the Company's broader strategy for global deployment and adoption of its PCR platform. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management as of the date of this release. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks related to the Company's ability to obtain necessary regulatory approvals in multiple jurisdictions; the timing and results of clinical studies; uncertainties associated with market acceptance and adoption of the Company's products; the ability to successfully establish and manage distribution relationships; the Company's ability to manufacture and supply its products, including through third-party partners such as CoSara; competitive dynamics in the global molecular diagnostics market; execution risks associated with international expansion; and general economic, geopolitical, and public health conditions in the regions in which the Company operates or intends to operate. 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 27, 2025, 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Co-Diagnostics (CODX) ship to India on March 25, 2026 for TB clinical studies?

Co-Diagnostics shipped PCR Pro instruments, Co-Dx PCR MTB test kits and sample-preparation devices to India. According to the company, these materials are needed to begin clinical performance studies with its joint venture CoSara Diagnostics.

How does the WHO guidance affect Co-Diagnostics' TB test (CODX)?

The WHO recommended near-point-of-care molecular testing and tongue swabs for TB, which aligns with Co-Dx test design. According to the company, the PCR platform and NPOC TB kit are already consistent with that WHO guidance, supporting clinical evaluation plans.

Has Co-Diagnostics received any Indian regulatory approvals for its PCR Pro instrument (CODX)?

Yes; Co-Diagnostics announced a CDSCO license to manufacture and sell the PCR Pro instrument in India. According to the company, this license covers manufacturing and sale but further regulatory steps are needed for clinical study submissions.

When will Co-Diagnostics (CODX) start TB clinical performance studies in India?

The company expects to commence clinical performance studies in India in the near term as it completes final steps. According to the company, shipments to CoSara have been made to enable initiation once those steps are finished.

Does Co-Diagnostics' PCR platform have FDA clearance for sale in the U.S. (CODX)?

No; the Co-Dx PCR platform and associated tests remain subject to FDA and other regulatory review and are not yet available for sale. According to the company, U.S. regulatory review is ongoing and clearance has not been issued.

What TB incidence context did Co-Diagnostics cite in the March 25, 2026 announcement (CODX)?

The company cited the WHO report noting only a 12% global reduction in TB incidence since 2015 and that India accounts for roughly 25% of global cases. According to the company, this underscores the need for expanded TB testing access.