WHO launches a pilot parallel WHO Prequalification and TB policy assessment process for new TB IVDs

To streamline and optimize WHO assessment of new in vitro diagnostics, the WHO Prequalification Unit (PQT) within the Department of Regulation and Prequalification (RPQ) and Department for HIV, TB, Hepatitis, and STIs (HTH) are pleased to announce a partnership to pilot a novel parallel assessment process. In 2025, HTH will assess evidence on a new, near point-of-care class of tuberculosis (TB) diagnostic technologies that will inform updated TB policy guidance, while PQT will simultaneously assess individual near point-of-care testing class products for possible prequalification. The molecular tests in this new diagnostic class are expected to expand access to needed testing services because they can be done using easy-to-collect tongue swabs as a new sample type for TB detection. This parallel process is envisioned to speed WHO assessment of the impact, quality, and safety of near point-of-care tests with the potential to expand access to needed TB diagnostic services. Manufacturers of eligible products are invited to contact the WHO Prequalification Unit at diagnostics@who.int to schedule a pre-submission call.