A molecular test that could take tuberculosis diagnosis out of the central laboratory and closer to the patient is now awaiting regulatory clearance in India. CoSara Diagnostics, the Indian joint venture of US-based Co-Diagnostics, has completed a clinical performance study of its point-of-care TB test and filed it with the Central Drugs Standard Control Organization (CDSCO).

The CoSara PCR Mycobacterium tuberculosis (MTB) test runs on the CoSara PCR Pro, a compact real-time PCR instrument that returns results in roughly 30 minutes and is read through a mobile application. The companies say they expect a CDSCO decision in the fourth quarter of 2026, which would allow commercial sales to begin before the end of the year.

What the Indian study found

The clinical evaluation was carried out at select laboratories in India and its documentation forms part of the regulatory dossier. Key findings shared by the company:

• 676 clinical samples were assessed, of which 233 were paired with MGIT (mycobacterial growth indicator tube) culture testing to generate the comparative results.
• 97.3% average sensitivity and 96.0% average specificity against the reference standard for TB detection.
• Consistent performance across three separate test batches, which the company highlights as evidence of manufacturing reproducibility.

The study began in July 2026, when PCR Pro instruments, MTB test kits and sample-preparation equipment were deployed to Indian labs for evaluation. The application remains subject to CDSCO review, including any further requirements the regulator may raise.

Built for decentralised, low-connectivity settings

The digital design of the platform is as important as the assay. Co-Diagnostics says it has already deployed its integrated mobile and cloud infrastructure in India ahead of launch. Test analysis happens on a mobile device, and the system is designed to keep working without a continuous internet connection, syncing results to the cloud once connectivity returns.

For a disease where delays between sample collection, lab processing and reporting often cost weeks, a device that can run gold-standard PCR chemistry outside a centralised lab, and still feed structured data upstream, fits directly into India’s push for faster case-finding at primary and community level. The test uses the company’s patented Co-Primers technology.

Who is behind CoSara

CoSara Diagnostics was set up in 2017 as a joint venture between Co-Diagnostics and Synbiotics, a subsidiary of Ahmedabad-based Ambalal Sarabhai Enterprises, to manufacture and commercialise molecular diagnostic instruments and assays in India. Co-Dx PCR platform products, including test kits and the sample lysis instrument, are expected to be made and distributed in India under the CoSara brand.

“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.

Next steps

Once clearance is granted, CoSara plans to start sales across India and parts of South Asia through its own sales team and distributors, backed by product demonstrations and outreach in targeted markets. The company notes that the Co-Dx PCR platform and its tests are not yet available for sale and remain subject to authorisation by regulators in each market, so the Indian rollout depends on the CDSCO decision.

If approved, the test would add another Indian-made option to the growing toolkit of rapid molecular diagnostics aimed at bringing TB testing closer to where patients first seek care.

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