BD announced that the Conformité Européenne (CE) Marked BD Onclarity HPV Assay for the BD COR System and the BD Viper LT System have been accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostic products, further expanding access to high-quality cervical cancer screening tools in low- and middle-income countries.
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.
"Achieving WHO prequalification is an important step toward changing the future of cervical cancer screening, especially in low- and middle-income countries where the burden is greatest and access to screening is often limited," said Nikos Pavlidis, worldwide president of Diagnostic Solutions at BD. "Cervical cancer is a preventable disease, and by expanding access to potentially life-saving diagnostics, we're helping ensure that more women have the opportunity to be screened, treated, and protected. Together, with our global partners, we can accelerate progress toward eliminating cervical cancer worldwide."
