WHO opened a prequalification pathway for interferon gamma release assays (IGRAs) and targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics. The initiative is intended to independently assess test safety, quality and performance for procurement by countries and international groups. WHO’s launch webinar outlined that the process will begin by establishing policies defining how different testing categories should be used across diseases. WHO also listed first-in-class policies including five IGRA tests and three tNGS tests, with applications planned to open on Sept. 1, 2026. For manufacturers, the pathway includes options such as abridged dossiers for products with certain regulatory clearances and ISO certifications, plus a full dossier review option open to qualifying manufacturers once Technical Specifications Series (TSS) performance criteria are published next year.