WHO opened its prequalification pathway for targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics and interferon gamma release assays (IGRAs), establishing an independent review route for countries and international procurement. WHO said applications will open Sept. 1, 2026. The agency also published policies outlining which test categories proceed under abridged or full dossier reviews depending on prior global regulatory clearances and certifications like ISO. For developers, the new pathway could reduce time-to-procurement barriers for higher-capability TB diagnostics in settings that rely on WHO prequalification for tender eligibility.
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