CoSara files its 30-minute point-of-care TB PCR test with CDSCO after reporting 97.3% sensitivity
Co-Diagnostics says its Indian joint venture CoSara has submitted a TB PCR test to CDSCO after a 676-sample study. Reported sensitivity and specificity come from a 233-sample comparative subset; clearance remains pending.
A tuberculosis test that gives a molecular result in about half an hour, without a central laboratory, is now before India's drug regulator. On 27 October 2026, CoSara Diagnostics, an Indian joint venture of US-based Co-Diagnostics, said it had completed a clinical performance study of its PCR-based TB test and submitted it to the Central Drugs Standard Control Organisation (CDSCO) for clearance.
If approved, the test would join a small but growing set of point-of-care molecular tools aimed at the place where India's TB fight is most often lost: the gap between a patient's first visit to a clinic and a confirmed diagnosis.
What the study found
According to the companies, the clinical study assessed 676 clinical samples, 233 of which were paired with MGIT testing. MGIT, a liquid-culture method, is one of the reference standards for detecting Mycobacterium tuberculosis, but it can take days to weeks to return a result.
Across three production batches of the test, CoSara reported:
- Average sensitivity of 97.3%, meaning the test correctly identified that share of TB-positive samples.
- Average specificity of 96.0%, meaning it correctly cleared that share of TB-negative samples.
These are company-reported figures from a study the company ran. The announcement does not provide a complete peer-reviewed dataset or establish regulatory clearance. The reported comparative results are based on the 233 samples paired with MGIT, rather than all 676 samples.
How the test works
The test runs on the CoSara PCR Pro, a compact real-time PCR instrument. PCR (polymerase chain reaction) detects the genetic material of the TB bacterium directly, rather than looking for it under a microscope or waiting for it to grow in culture. The instrument returns results in roughly 30 minutes through a mobile application and does not need central laboratory infrastructure.
Who is behind it
CoSara was formed in 2017 as a joint venture between Co-Diagnostics, a Salt Lake City-based molecular diagnostics company, and Synbiotics, a subsidiary of Ahmedabad-based Ambalal Sarabhai Enterprises. The joint venture manufactures in India and has been the main route for Co-Diagnostics' products into the Indian market.
Why it matters for India
India carries the largest share of the world's tuberculosis burden, and the government has made TB elimination a national priority. A central problem is diagnosis. Sputum smear microscopy, still widely used, misses a significant share of cases. Culture is accurate but slow. Molecular tests are both fast and accurate, but many require laboratory equipment, stable power and trained staff that primary health centres do not always have.
Every delay matters. A patient who is not diagnosed on the first visit may not come back, and an undiagnosed patient keeps spreading the infection. That is why point-of-care molecular testing, which aims to bring molecular diagnosis closer to a clinic or mobile van, has become a priority for India's TB programme and for global health funders.
The mobile-app design is also relevant to India's digital health push. Results that come out of an app can, in principle, flow more easily into patient tracking and notification systems, although the companies have not said how the test will connect to the government's existing TB reporting platforms.
A test built for decentralised care
The design choices behind the PCR Pro reflect where TB patients in India actually show up. Many first seek care at private clinics, chemists or small government facilities rather than at district hospitals with full laboratories. A test that can run on a compact instrument, report through a phone and skip the sample transport to a central lab could shorten the diagnostic journey for those patients. It could also be useful for active case-finding, where health workers screen people in high-risk communities, prisons or workplaces instead of waiting for them to come to a clinic.
Local manufacturing matters too. Domestic manufacturing could help supply resilience, but reagent sourcing, pricing and eligibility for government tenders are not established by this announcement.
What happens next
CDSCO's review is under way, and the companies note that the regulator may ask for more data. Co-Diagnostics has said it expects a decision in the fourth quarter of 2026 and hopes to begin commercial sales in India before the end of the year. That timeline is the company's projection, not a regulatory commitment.
The bigger tests come after approval: independent evaluations in Indian field conditions, inclusion in government procurement, and per-test pricing. Strong numbers in a company study are a start. Performance in crowded district hospitals and primary health centres, where the test is meant to be used, will decide whether it changes how quickly Indian patients learn they have TB.