WHO opened a prequalification pathway for interferon gamma release assays (IGRAs) and targeted next-generation sequencing (tNGS)-based in vitro tuberculosis diagnostics, enabling independent assessment for procurement by countries and global groups. WHO said applications for IGRA and tNGS assays will open Sept. 1, 2026, with “first-in-class” policies allowing for potentially abridged dossier reviews based on established categories and certain global regulatory clearances. For developers, the new pathway provides a structured route to expand access to high-performance TB tests and clarifies expected documentation through ISO and regulatory certification requirements.