BD (Becton, Dickinson and Company) has received World Health Organization (WHO) prequalification for its CE-Marked BD Onclarity™ HPV Assay for both the BD COR™ System and the BD Viper™ LT System—an important milestone in increasing global access to high-quality cervical cancer screening, particularly in low- and middle-income countries (LMICs).
The newly prequalified Onclarity™ assay detects 14 high-risk HPV types, including six individually identified types and three genotype groups. This extended genotyping supports more precise risk stratification and helps clinicians tailor follow-up and management for women based on their specific HPV profile. The assay is also approved for self-collection—including at-home self-collection in CE-mark–recognizing countries—improving access for women in underserved or hard-to-reach areas.
Enhanced individual HPV identification enables clinicians to better identify high-risk cases requiring urgent attention while reducing unnecessary follow-ups for lower-risk patients. This reduces the burden on screening programs while ensuring patients receive care appropriate to their risk level.
The BD Onclarity™ HPV Assay is already approved in the U.S. and CE-recognizing countries for extended high-risk HPV genotyping and self-collection in clinical settings. In the U.S., it is the only assay authorized for both extended genotyping beyond HPV 16, 18, and 45 and self-collection in healthcare environments. The WHO prequalification specifically applies to the EU CE-Marked assays.
BD’s molecular platforms widen access across diverse healthcare environments:
· BD Viper™ LT System: A compact, benchtop solution designed for decentralized and resource-limited settings. It automates sample preparation and amplification, minimizes hands-on steps, and supports consistent results—ideal for regional laboratories and public health programs without access to high-throughput systems.
· BD COR™ System: A high-throughput platform for centralized laboratories capable of processing up to 1,650 tests and delivering approximately 1,000 sample results in 24 hours. With barcode-driven traceability, remote system management, up to seven hours of walk-away time, and reagents that require no reconstitution, the system maximizes efficiency and reduces manual workload.
Cervical cancer remains a major global health challenge—one woman dies every 90 seconds, and it is the fourth most common cancer among women. Despite this burden, the disease is preventable through effective screening. WHO’s global strategy emphasizes HPV primary screening, extended genotyping, and self-collection to improve early detection and treatment. WHO prequalification ensures that diagnostic assays used in national programs meet international standards for quality, safety, and performance.
The addition of BD’s Onclarity™ HPV Assay to the WHO prequalified list strengthens global efforts toward eliminating cervical cancer as a public health problem and expands access to reliable, high-quality screening tools in LMICs.
