WHO opened its prequalification pathway for interferon gamma release assays and targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics. The move is intended to support independent assessment of safety, quality, and performance for procurement by countries and international groups. WHO said it has published policies defining use categories across diseases and listed first-in-class options—five IGRAs and three tNGS tests—in those policy documents. Applications for WHO prequalification assessment are scheduled to open Sept. 1, 2026, with dossier expectations calibrated to prior regulatory clearances and ISO certifications—an important step for scaling TB diagnostics in global markets.