The World Health Organization granted prequalification to Becton Dickinson’s Onclarity HPV assay for use on BD Cor and BD Viper LT molecular platforms, clearing the test for procurement in low‑ and middle‑income countries. The PCR assay provides extended genotyping for 14 high‑risk HPV types and supports risk stratification in cervical‑cancer screening programs. BD noted prior FDA PMA and CE marks and emphasized compatibility with self‑collection workflows, which can improve screening uptake. WHO prequalification should facilitate distribution by international aid groups and national programs seeking validated IVDs for population screening.