Core Insights - BD (Becton, Dickinson and Company) has received WHO prequalification for its Onclarity™ HPV Assay, enhancing access to cervical cancer screening in low- and middle-income countries [1][4]. Product Details - The BD Onclarity™ HPV Assay detects 14 high-risk HPV types, allowing for individual identification of six high-risk types and three genotype groups, which aids in risk stratification and patient management [2][3]. - The assay is approved for self-collection, including at-home self-collection in countries recognizing the CE mark, thus improving access in resource-limited settings [2][4]. Impact on Healthcare - The ability to identify more individual HPV types enables clinicians to manage high-risk cases more effectively and guide follow-up for low-risk patients, ensuring appropriate care and reducing resource demand [3][4]. - WHO emphasizes the importance of regular screening to prevent cervical cancer, which is the fourth most common cancer in women globally, with a woman dying from it every 90 seconds [7]. System Features - The BD Viper™ LT System is designed for decentralized testing, featuring a compact design that automates sample preparation and amplification, making it suitable for labs with limited infrastructure [5]. - The BD COR™ System offers high-throughput automation for centralized labs, capable of processing nearly 1,650 tests and delivering up to 1,000 results in 24 hours, maximizing efficiency [6].
BD Onclarity™ HPV Assay for BD COR™ and BD Viper™ LT Systems Receive WHO Prequalification