Co-Diagnostics Advances India Launch of Point-of-Care TB Test After Clinical Study

CoSara PCR Pro instrument, an India-branded version of Co-Diagnostics' Co-Dx PCR Pro point-of-care platform, delivers real-time PCR results in approximately 30 minutes through a mobile application.

Utah-based Co-Diagnostics has completed the clinical performance study of its point-of-care tuberculosis (TB) test in India and submitted the product for regulatory clearance, bringing the company closer to a potential commercial launch before the end of 2026.

The test, developed by its Indian joint venture CoSara Diagnostics, recorded 97.3% average sensitivity and 96.0% average specificity during the evaluation.

Co-Diagnostics is a molecular diagnostics company that develops polymerase chain reaction (PCR)-based testing technologies. Its joint venture, CoSara Diagnostics, was established in 2017 with Synbiotics, a subsidiary of Ambalal Sarabhai Enterprises, to manufacture and commercialise molecular diagnostic instruments and assays in India.

The latest development follows the company's efforts to establish the technology and digital infrastructure needed to support decentralised testing.

The clinical study evaluated 676 clinical samples, including 233 paired with mycobacterial growth indicator tube (MGIT) testing, which formed the basis of the reported comparative performance results.

Across three test batches, the CoSara PCR Mycobacterium tuberculosis (MTB) test demonstrated an average sensitivity of 97.3% and specificity of 96.0% against the reference standard. The study was conducted in India, and its documentation has been included in the regulatory submission.

The application is now under review by India's Central Drugs Standard Control Organization (CDSCO). Co-Diagnostics and CoSara expect regulatory approval in the fourth quarter of 2026, which could enable commercial sales to begin before year-end. The launch remains subject to regulatory clearance.

The test runs on the CoSara PCR Pro instrument, an India-branded version of Co-Diagnostics' Co-Dx PCR Pro point-of-care platform.

It uses the company's patented Co-Primers technology to deliver real-time PCR results in approximately 30 minutes through a mobile application, without requiring centralised laboratory infrastructure.

Co-Diagnostics has also deployed its integrated mobile and cloud infrastructure in India to support the anticipated launch. The system enables test analysis through a mobile device and is designed to operate without a continuous internet connection.

Test data can be synchronised with the cloud when connectivity becomes available, supporting data management across decentralised testing locations.

"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.

Following regulatory clearance, CoSara plans to begin sales activities across India and parts of South Asia, supported by its direct sales team, distributors, product demonstrations and customer outreach.

The Co-Dx PCR platform and its associated tests remain subject to review or authorisation by the relevant regulatory authorities in the markets where approval is sought. The anticipated Indian launch will therefore depend on CDSCO clearance.

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