Co-Diagnostics' India JV CoSara files regulatory submission for TB PCR test after clinical validation
Co-Diagnostics' joint venture CoSara Diagnostics in India completed a clinical performance study of its PCR Mycobacterium tuberculosis test, reporting 97.3% sensitivity and 96.0% specificity. The company submitted the assay to India's Central Drugs Standard Control Organization for clearance, with an expected approval in the fourth quarter of 2026. CoSara has also rolled out its integrated mobile and cloud infrastructure to support decentralized testing. The firm anticipates launching commercial sales in India before year‑end 2026 if the regulator approves the test.
Why it matters
The company expects regulatory approval in Q4 2026, which would allow CoSara to begin selling the TB test in India before the end of the year, expanding its market presence in the country with the highest global TB burden (the company says).
Key facts
- 1The clinical performance study evaluated 676 patient samples, of which 233 were paired with MGIT testing for comparative analysis. prnewswire.com
- 2Across three test batches, the assay achieved an average sensitivity of 97.3% and an average specificity of 96.0% versus the reference standard. prnewswire.com
- 3CoSara submitted the PCR MTB test to India's CDSCO for regulatory clearance on Oct. 27 2026. prnewswire.com
- 4Co-Diagnostics expects CDSCO approval in the fourth quarter of 2026, targeting commercial sales in India before year‑end 2026. prnewswire.com
- 5The joint venture has deployed integrated mobile and cloud infrastructure in India to enable decentralized testing and data synchronization. prnewswire.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.