Co-Diagnostics JV Earns Key ISO Certification for PCR Plant in India

SALT LAKE CITY, UT & VADODARA, INDIA – February 04, 2026 – CoSara Diagnostics, a joint venture of the U.S.-based Co-Diagnostics, Inc., has secured a pivotal international certification for its manufacturing facility in India, a move that significantly advances its goal of launching a new, affordable PCR testing platform in one of the world's largest healthcare markets.

CoSara announced today that its quality management system (QMS) at the Vadodara facility has been granted ISO 13485:2016 certification. This globally recognized standard is a critical prerequisite for medical device manufacturers seeking to prove their processes meet the highest levels of safety and quality. For Co-Diagnostics and CoSara, the certification is a crucial stepping stone toward gaining regulatory clearance for their upcoming molecular diagnostic platform and its associated tests.

A Gateway to India's Burgeoning Diagnostics Market

The ISO 13485 certification is more than a plaque on the wall; it is a key that unlocks regulatory pathways. In India, the Central Drugs Standard Control Organisation (CDSCO) governs the approval of all In Vitro Diagnostics (IVDs) under the Medical Devices Rules, 2017. This framework requires manufacturers to provide exhaustive documentation, including a valid ISO 13485 certificate, to demonstrate a robust QMS. Achieving this standard signals to regulators that CoSara's manufacturing processes are compliant, consistent, and capable of producing reliable medical devices.

"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," remarked Mohal Sarabhai, CEO of CoSara. He emphasized its importance for regulatory clearance, stating, "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 immediate focus for the newly certified facility will be the manufacturing of Co-Diagnostics' innovative PCR platform. This includes the development of crucial tests for high-burden diseases like tuberculosis (MTB) and a multiplex test for eight types of human papillomavirus (HPV), both of which represent significant public health challenges in India and globally.

Leveraging the 'Make in India' Advantage

Establishing manufacturing operations in India is a strategic move that aligns with the Indian government's 'Make in India' initiative. This national program is designed to transform India into a global manufacturing hub by encouraging both domestic and multinational companies to manufacture their products within the country. For the medical device sector, this policy aims to reduce reliance on imports, lower healthcare costs, and foster indigenous innovation.

By producing its PCR instruments and test kits locally, CoSara can tap into significant economic benefits. "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," commented Dwight Egan, CEO of Co-Diagnostics. These savings can be passed on to consumers, making advanced diagnostics more accessible and affordable.

The 'Make in India' framework, supported by policies like the National Medical Devices Policy of 2023, offers a range of incentives, including streamlined regulatory processes and potential fiscal benefits. For Co-Diagnostics, this means not only improved cost-efficiency but also a stronger competitive position in a market traditionally dominated by more expensive, imported technologies.

The Race to Revolutionize Point-of-Care Testing

The ultimate goal of the Co-Diagnostics platform is to decentralize molecular testing, moving it from centralized labs to point-of-care and even at-home settings. The platform, which includes the PCR Home™ and PCR Pro™ devices, is designed to be user-friendly and affordable, addressing a critical gap in the current diagnostics landscape.

In India, where an estimated 41 million tuberculosis tests are performed annually, the need for rapid and accessible diagnostics is immense. While advanced PCR tests like Cepheid's Xpert have improved detection, their high cost and infrastructure requirements—such as continuous power and temperature control—limit their use in remote and resource-constrained areas. This is the market opportunity Co-Diagnostics aims to capture.

Tangible progress is already being made. The certification announcement coincided with a recent visit to India by Co-Diagnostics' technical team, including Chief Technology & AI Officer Christopher Thurston. The team was on-site to finalize the software for the MTB and HPV tests and to scout locations for upcoming clinical performance studies, underscoring the project's advancement from development to the pre-commercialization phase.

Navigating the Path from Certification to Commercialization

For Co-Diagnostics, which is currently in a pre-revenue phase for this new platform, the ISO certification is a vital de-risking event. The company has been investing heavily in research and development, and this milestone provides tangible proof of progress and quality control to investors and partners. It validates the company's strategic investment in its Indian joint venture and moves it one step closer to generating revenue from its flagship technology.

However, the path to market is still rigorous. The company is careful to note that the entire Co-Dx PCR platform and its associated tests are subject to review by the FDA in the United States and other regulatory bodies like the CDSCO in India. The products are not yet available for sale, and the company must still successfully navigate clinical trials and the final regulatory approval process.

With the ISO 13485 certification now in hand, CoSara has cleared a major administrative and quality hurdle. The focus now shifts to completing clinical validations and preparing the comprehensive submission dossiers required to bring this potentially game-changing diagnostic technology to the millions who need it.