The BD Onclarity HPV Assay detects 14 high-risk HPV types and supports self-collection.
BD (Becton, Dickinson and Company) announced that its CE-marked BD Onclarity HPV Assay for the BD COR System and BD Viper LT System has been accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostic products.
The prequalification expands access to cervical cancer screening tools in low- and middle-income countries, where the disease burden is highest and screening access is often limited.
The BD Onclarity HPV Assay detects 14 high-risk human papillomavirus types, including individual identification of six high-risk types and three genotype groups. The extended genotyping capability enables more precise risk stratification and supports effective patient management in cervical cancer screening programs.
The assay is approved for self-collection, including at-home self-collection in countries that recognize the CE mark. This capability enables improved access in settings with limited resources by covering all available collection and testing modalities.
“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,” says Nikos Pavlidis, worldwide president of diagnostic solutions at BD, in a release. “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.”
System Capabilities Support Diverse Laboratory Settings
The BD Viper LT System supports flexible testing in decentralized settings with a compact, benchtop design that enables molecular diagnostics in laboratories with limited space or infrastructure. The system automates sample preparation and amplification, reducing manual steps and supporting consistent results.
The BD COR System offers high-throughput automation for centralized laboratories, with capacity for nearly 1,650 tests while delivering up to 1,000 sample results in 24 hours. The system provides up to seven hours of walk-away time, requires under 15 minutes to load, and uses room-temperature reagents that need no reconstitution.
The ability to identify more individual HPV types allows clinicians to more effectively manage high-risk cases and better guide follow-up for low-risk patients. This targeted approach helps ensure appropriate care and reduces demand for resources supporting follow-up testing and procedures.
Addressing Global Cervical Cancer Burden
According to WHO, a woman dies of cervical cancer every 90 seconds. Cervical cancer is the fourth most common cancer in women worldwide in terms of both incidence and deaths, but it is preventable with regular screening.
WHO aims to eliminate cervical cancer as a public health issue. Global consensus is moving toward HPV primary screening with extended genotyping and self-collection, as reflected in WHO guidelines. WHO prequalification for HPV tests ensures those tests meet global standards for quality, safety, and performance for use in cervical cancer screening programs.
In the US, the BD Onclarity HPV Assay is the only assay approved for both extended genotyping of individual results beyond HPV 16, 18 and 45 and self-collection in healthcare settings. WHO prequalification is specific to the EU CE-marked BD Onclarity HPV assays.
Photo caption: BD Onclarity HPV assay for BD COR and BD Viper LT Systems receives WHO prequalification
Photo credit: BD
