Co-Diagnostics JV, CoSara, Receives ISO 13485 Certification in Preparation for Manufacturing Upcoming PCR Platform

Rhea-AI Summary

Co-Diagnostics (OTC: CODX) said its joint venture CoSara has received ISO 13485:2016 certification for its Vadodara, India manufacturing facility on Feb 4, 2026. The certification validates the joint venture's quality management system and supports regulatory submissions for an upcoming PCR platform and associated tests.

Company staff visited India to finalize MTB and HPV test software, inspect clinical study sites, and support manufacturing lines; the PCR platform remains subject to FDA and other regulatory review and is not yet for sale.

Positive

• ISO 13485:2016 certification for Vadodara manufacturing facility (Feb 4, 2026)
• Certification supports regulatory submissions for the upcoming PCR platform
• On-site finalization of MTB and HPV test software completed during India visit
• Manufacturing lines positioned to support commercialization of test cups and PCR instruments
• Potential qualification for 'Make in India' initiative enabling local cost advantages

Negative

• PCR platform remains subject to FDA and other regulatory review and is not yet for sale
• Commercial launch depends on successful regulatory clearance and clinical performance studies

Company and CoSara believe that ISO certification is a critical component of the regulatory requirements for clearance of new platform

SALT LAKE CITY, Feb. 4, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (OTC: 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 between Co-Dx and Ambalal Sarabhai Enterprises Limited (ASE Group), has successfully completed the necessary audits of its quality management system ("QMS") and that its manufacturing facility located in Vadodara, India, has been granted ISO 13485:2016 certification.

Mohal Sarabhai, CEO of CoSara, remarked, "Receiving this certification is a major milestone for CoSara, and validates the diligent work of our Quality team in building, streamlining, and maintaining our QMS to the highest international standards. We believe this certification will be a critical component to demonstrate to regulatory bodies in India and abroad that we meet the requirements for regulatory clearance of the upcoming PCR platform*, as well as for other medical device products across our full suite of offerings."

The audits included a review of CoSara's QMS to ensure compliance with ISO 13485:2016, the international standard in quality management for organizations involved in the design, development and manufacture of medical devices. ISO 13485 certification ensures best practices in the manufacture of medical devices, while facilitating market access across different countries and enhancing trust among stakeholders.

The completion of the audits also coincided with a recent visit to India by Co-Dx staff, including Chief Technology & AI Officer Christopher Thurston. Team members were on-site to support the final steps in finalizing the software that will be used in the MTB (tuberculosis) test and PCR HPV 8-type multiplex test, to visit locations for upcoming clinical performance studies for these tests, and to support the manufacturing lines for commercialization of the test cups and the PCR instrument.

"ISO 13485 certification is a vital step towards regulatory submission and IVD clearance of the new platform, as well as for qualifying for the 'Make in India' initiative," commented Dwight Egan, Co-Dx CEO. "Manufacturing instruments and test kits in-country under the initiative will allow the PCR platform to benefit from the cost-saving advantages compared to importing into India."

The International Organization of Standards ("ISO") is a non-governmental entity comprised of academic and industry professionals that certifies companies as compliant with industry-standard best practices in their production and operations.

*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) 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, its manufacture in India, IVD clearance and future CoSara regulatory submissions to the CDSCO, including statements about potential or future clinical performance studies, 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 about ISO certification on Feb 4, 2026?

Co-Diagnostics announced that JV CoSara received ISO 13485:2016 certification for its Vadodara manufacturing facility. According to the company, the certification follows completed QMS audits and validates manufacturing quality for the upcoming PCR platform.

How does CoSara's ISO 13485 certification affect CODX's PCR platform regulatory plans?

The certification supports regulatory submission efforts by demonstrating a compliant QMS for device manufacture. According to the company, ISO 13485 will be a critical component when seeking IVD clearance from FDA and other regulators.

Will Co-Diagnostics (CODX) manufacture PCR instruments in India under the 'Make in India' initiative?

Yes. Co-Diagnostics said manufacturing instruments and test kits in India aims to qualify for 'Make in India' benefits and reduce import costs. According to the company, in-country production can provide cost advantages for commercialization.

What development work did CODX staff complete during the India visit related to MTB and HPV tests?

Co-Diagnostics staff finalized software for the MTB test and PCR HPV 8-type multiplex test and visited clinical study sites. According to the company, the visit also supported manufacturing line readiness for commercialization.

Is the Co-Dx PCR platform (CODX) available for sale after the ISO certification?

No. The PCR platform is not yet available for sale and remains subject to FDA and other regulatory review. According to the company, ISO certification helps prepare for regulatory submission but does not constitute market clearance.