Co-Diagnostics Ships TB Diagnostic Materials to India Amid WHO Guidance Shift
Event summary
- Co-Diagnostics shipped PCR Pro® instruments and TB test kits to India for clinical studies.
- WHO issued new guidance on March 9, 2026, recommending near-point-of-care TB tests and tongue swab samples.
- Co-Diagnostics' PCR platform aligns with WHO's new recommendations for TB testing.
- India accounts for 25% of global TB cases despite a 21% reduction in incidence since 2015.
- PCR Pro® instrument received a license from the CDSCO for manufacture and sale in India.
The big picture
The WHO's new guidance on near-point-of-care TB testing and tongue swab samples creates a strategic opportunity for Co-Diagnostics to align its PCR platform with global health priorities. With India accounting for a quarter of global TB cases, the company's ability to navigate regulatory hurdles and demonstrate clinical efficacy will be critical for market penetration. The shift towards accessible, molecular diagnostics for TB reflects broader trends in infectious disease management, emphasizing early and accurate testing to reduce diagnostic gaps.
What we're watching
- Regulatory Alignment
- How quickly Co-Diagnostics can secure regulatory clearances in India and other jurisdictions for its TB test.
- Market Adoption
- Whether the WHO's new guidance will accelerate demand for near-point-of-care TB testing solutions.
- Clinical Validation
- The pace at which clinical performance studies in India will validate the efficacy of Co-Diagnostics' TB test.