Co-Diagnostics venture seeks Indian regulatory clearance for TB test
CODX•Co-Diagnostics’ Indian joint venture CoSara submitted its point-of-care tuberculosis test to India’s CDSCO for regulatory clearance. Approval is expected in the fourth quarter of 2026, with clinical testing showing average sensitivity of 97.3% and specificity of 96%.
1. Regulatory submission
CoSara submitted its point-of-care tuberculosis test to India’s CDSCO for regulatory clearance. Regulatory approval is expected in the fourth quarter of 2026, positioning CoSara for an Indian commercial launch before year-end.
2. Clinical results
Clinical testing showed average sensitivity of 97.3% and specificity of 96% across three test batches.
