WHO has officially opened its prequalification pathway for targeted next-generation sequencing (tNGS) and interferon gamma release assays (IGRAs) for tuberculosis in vitro diagnostics. The initiative is designed to support independent assessment of test safety, quality, and performance for procurement by countries and international groups. WHO said the process will proceed after establishment of policies for different testing categories across diseases. During the launch webinar, WHO also indicated it has listed five IGRAs and three tNGS tests as first-in-class in its policy documents, while clarifying that inclusion does not guarantee prequalification. Applications for WHO prequalification assessment of IGRA and tNGS assays will open Sept. 1, 2026, with abridged dossier options available for developers meeting regulatory-clearance and ISO criteria. The move may accelerate global uptake of newer TB diagnostic modalities beyond traditional platforms.