The World Health Organization (WHO) invites all stakeholders to provide comments by 5 December 2025 on the draft Guidance on Evidence Generation (GEG) for new tuberculosis diagnostics (available here), by using this feedback form.
The GEG is intended for researchers and other stakeholders involved in generating evidence to inform future WHO policy and operational guidance on tuberculosis (TB) diagnostic testing. Its objectives are to:
1. Describe the key steps of the WHO guideline development process;
2. Provide practical, study‑level guidance on how to plan, conduct and report research on the potential health benefits and harms of new TB diagnostic interventions, including new technologies, sample types, and testing strategies. It places specific attention on diagnostic accuracy studies but also covers studies on end-user values, resource requirements, cost-effectiveness, equity, acceptability and feasibility; and
3. Serve as a consolidated, high-level reference on WHO guideline development, prequalification and other WHO processes relevant for the introduction of new TB diagnostics.
As new technologies, sample types and strategies for TB diagnostic testing emerge, this guidance aims to promote the generation of high-quality evidence on their impact that can support development of robust WHO policies on testing, enabling strong and actionable recommendations for patients and disease control programs.
This draft of the GEG has been developed after in-depth consultation with researchers, national TB programmes, technical agencies, regulatory agencies, civil society organisations, and donors. The final version of the GEG is expected to be published in the first half of 2026, after incorporation of feedback during this public comment period and further expert review.
For more information, please contact GTBPCI@who.int.