Co-Diagnostics Joint Venture CoSara Receives CDSCO License to Manufacture and Sell CoSara PCR Pro™ Instrument

Rhea-AI Summary

Co-Diagnostics (OTC: CODX) joint venture CoSara received a CDSCO Form MD-5 license on Feb 5, 2026, authorizing manufacture of the CoSara PCR Pro real-time PCR point-of-care instrument at its Ranoli, India facility for sale or distribution.

This instrument license is described as the final CDSCO instrument approval required before commercialization; the CoSara-branded PCR Pro will be manufactured and distributed in India and run with CoSara PCR test kits, which require separate regulatory clearance prior to use as IVDs.

Positive

• CDSCO Form MD-5 instrument license secured for Ranoli manufacturing
• Enables manufacture and distribution of CoSara PCR Pro in India
• Represents final instrument license required prior to commercialization
• Joint venture supply chain: Co-Dx platform will be manufactured under CoSara brand

Negative

• CoSara PCR test kits (e.g., MTB, HPV) require separate regulatory clearance
• PCR Pro availability depends on IVD kit approvals before clinical use
• Co-Dx platform remains subject to FDA and other regulatory review outside India

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CDSCO license on Form MD-5 authorizes CoSara to manufacture PCR Pro instrument in its Ranoli, India facility for sale or distribution

SALT LAKE CITY, Feb. 5, 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 received a license from the Central Drugs Standard Control Organization ("CDSCO") to manufacture the CoSara PCR Pro™ real-time PCR point-of-care instrument for sale or distribution.

Mohal Sarabhai, CEO of CoSara, remarked, "We believe this landmark regulatory achievement validates the integrity of our quality management system, and that receiving this license for the PCR Pro will also help to facilitate the regulatory clearance process for the upcoming CoSara PCR test cups."

The CoSara PCR Pro instrument is the CoSara-branded version of the Co-Dx™ PCR Pro point-of-care instrument*, developed specifically for decentralized PCR testing. Co-Dx PCR platform products, including PCR test kits and the sample lysis instrument, will be manufactured and distributed in India under the CoSara brand.

A CDSCO license issued on Form MD-5 authorizes CoSara to manufacture the CoSara-branded Class A medical device instrument at its manufacturing facility in Ranoli, India for purposes of sale or distribution. This represents the final instrument license required by the CDSCO prior to commencing commercialization. The CoSara PCR test kits that will be run on the PCR Pro instrument, including tests for Mycobacterium tuberculosis (MTB) and human papillomavirus (HPV), are subject to separate regulatory clearance prior to use as in vitro diagnostics ("IVDs") and are not yet available for sale.

Co-Diagnostics CEO Dwight Egan added, "We are pleased with the collaborative efforts between Co-Dx and CoSara throughout the CDSCO application and review process. This milestone represents a critical step toward achieving our shared vision of increased availability and accessibility of gold-standard PCR diagnostics in underserved areas where they are most needed."

The CDSCO is the Indian regulatory body for medical devices, pharmaceuticals and cosmetics, tasked with ensuring safety standards, efficacy, and quality of medical devices, pharmaceuticals, and cosmetics, in the country. The CDSCO is also responsible for regulating the import, manufacture, sale, and distribution of medical devices across the Indian subcontinent.

*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, all associated tests and licensed applications of the technology) 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.

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. 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 the Co-Dx PCR platform, its branding under the CoSara label, 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 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 the CoSara PCR Pro on February 5, 2026?

CoSara received a CDSCO Form MD-5 license to manufacture the CoSara PCR Pro instrument in Ranoli, India. According to the company this authorizes sale or distribution of the instrument but not the accompanying PCR test kits, which need separate IVD clearance.

Does the CDSCO license allow CoSara to sell PCR test kits in India now?

No; the CDSCO Form MD-5 license covers the instrument only and not test kits. According to the company the CoSara PCR test kits, including MTB and HPV, require separate regulatory clearance before they can be sold as IVDs.

What is the significance of the Ranoli manufacturing authorization for CODX shareholders?

The license permits local manufacture and distribution of the CoSara-branded PCR Pro instrument in India. According to the company this is the final instrument license required before instrument commercialization in the Indian market.

Will the CoSara PCR Pro be distributed under the Co-Diagnostics platform branding in India?

Yes; the CoSara PCR Pro is the CoSara-branded version of the Co-Dx PCR Pro instrument and will be manufactured and distributed in India under the CoSara brand. According to the company platform products will be produced locally under the joint venture.

Are there regulatory hurdles remaining after the CoSara instrument license for CODX products?

Yes; while the instrument license is complete, the CoSara PCR test kits need separate CDSCO/IVD clearances and the Co-Dx platform remains subject to FDA and other regulatory review. According to the company those approvals are still pending.