WHO’s prequalification rollout for targeted NGS and TB IGRAs is expected to widen access to next-generation tuberculosis diagnostics for global procurement. By defining policies and first-in-class test categories, WHO is setting a structured route for developers seeking procurement eligibility. The process centers on independent assessment of safety, quality, and performance and introduces both abridged and full dossier paths depending on prior global clearances. WHO’s timeline calls for applications to open Sept. 1, 2026. While prequalification is not automatic, the pathway can reduce uncertainty for manufacturers and support faster adoption of newer diagnostics in settings where TB remains a major health burden.
Get the Daily Brief