WHO opened a prequalification pathway for interferon gamma release assays (IGRAs) and targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics, enabling independent assessment for countries and international procurement. The initiative specifies that prequalification is not automatic upon inclusion in policy documents, with abridged versus full dossier reviews tied to existing regulatory clearances and ISO certifications. WHO said applications for prequalification assessment will open Sept. 1, 2026, and it will publish Technical Specifications Series documents next year describing performance evaluation criteria and comparator assays. Developers will use the electronic prequalification system to register and submit presubmission questions. The policy move can expand global access by standardizing how diagnostic quality and performance are judged for procurement beyond national regulators. For biotech and diagnostics manufacturers, the timeline and dossier structure provide a clear route to scale distribution for TB diagnostics in markets that rely on WHO prequalification.