The newly prequalified assay detects 14 high-risk human papillomavirus (HPV) types, including individual identification of six high-risk types and three genotype groups. Extended genotyping enables more precise risk stratification and supports effective patient management in cervical cancer screening programs. The BD Onclarity™ HPV Assay is approved for self-collection, including at-home self-collection in countries that recognize the CE mark. By covering all available collection and testing modalities, the solution enables improved access, especially in settings with limited resources.

The ability to identify more individual types of HPV means that clinicians can more effectively manage high-risk cases and better guide follow-up for low-risk patients. This targeted approach helps ensure that women receive the most appropriate care for their situation and reduces demand for resources that support follow-up testing and procedures.