Press release summary
CoSara Diagnostics has completed an Indian clinical performance study of its PCR test for Mycobacterium tuberculosis and submitted the test to India’s Central Drugs Standard Control Organization for regulatory review.
The study evaluated 676 clinical samples. Of those, 233 were paired with mycobacterial growth indicator tube testing and used for the reported comparative analysis. CoSara reported average sensitivity of 97.3% and average specificity of 96% across three test batches, with similar performance among the batches.
The assay runs on the CoSara PCR Pro point-of-care instrument, a branded version of Co-Diagnostics’ PCR Pro platform. The companies said the system produces real-time PCR results in about 30 minutes through a mobile application. A localized cloud system can synchronize test data after offline operation in decentralized settings.
The test and instrument remain subject to regulatory review and are not yet available for sale. The results matter to laboratory readers because they provide a defined clinical dataset for a decentralized molecular-testing workflow in a country with a substantial tuberculosis burden. Laboratories assessing point-of-care PCR also need to consider batch consistency, reference-method comparisons, data handling, connectivity, and quality oversight before a platform moves into routine use.
Original source: Co-Diagnostics’ Oct. 27, 2026 announcement.
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