BD Onclarity™ HPV Assay for BD COR™ and BD Viper™ LT Systems Receive WHO Prequalification
BD (NYSE: BDX) announced that the CE-marked BD Onclarity HPV Assay for the BD COR and BD Viper LT systems received WHO prequalification on November 17, 2025, enabling wider use in low- and middle-income countries.
The assay detects 14 high-risk HPV types with extended genotyping (six individual types plus three genotype groups), supports self-collection including at-home where CE is recognized, and targets improved risk stratification and follow-up. The BD COR offers ~1,650-test capacity and up to 1,000 results in 24 hours; BD Viper LT provides compact, decentralized molecular testing.
BD (NYSE: BDX) ha annunciato che il CE-marked BD Onclarity HPV Assay per i sistemi BD COR e BD Viper LT ha ricevuto prequalificazione OMS il 17 novembre 2025, permettendo un uso più ampio nei paesi a basso e medio reddito.
Il saggio rileva 14 tipi di HPV ad alto rischio con genotipizzazione estesa (sei tipi individuali più tre gruppi di genotipi), supporta l'auto-ricolta, inclusa a casa dove è riconosciuto il CE, e mira a migliorare la stratificazione del rischio e il follow-up. Il BD COR offre una capacità di ~1.650 test e fino a 1.000 risultati in 24 ore; il BD Viper LT fornisce un testing molecolare compatto e decentralizzato
BD (NYSE: BDX) anunció que el BD Onclarity HPV Assay con marca CE para los sistemas BD COR y BD Viper LT recibió la precalificación de la OMS el 17 de noviembre de 2025, lo que permite un uso más amplio en países de ingresos bajos y medios.
El ensayo detecta 14 tipos de HPV de alto riesgo con genotipo extendido (seis tipos individuales más tres grupos de genotipos), admite la autoextracción incluso en el domicilio donde se reconoce la CE, y tiene como objetivo mejorar la estratificación del riesgo y el seguimiento. El BD COR ofrece una capacidad de ~1.650 pruebas y hasta 1.000 resultados en 24 horas; el BD Viper LT proporciona pruebas moleculares compactas y descentralizadas.
BD (NYSE: BDX)는 CE 인증 BD Onclarity HPV Assay가 BD COR 및 BD Viper LT 시스템용으로 2025년 11월 17일 WHO 사전자격을 받아 저소득 및 중하위 소득 국가에서 더 넓은 사용이 가능해졌다고 발표했다.
이 분석은 고위험 HPV 14형을 확장된 유전자형화로 검출하되(여섯 가지 개별 유형과 세 가지 유전자형 그룹), CE가 인정되는 곳에서 자가수집을 지원하고 위험도 계층화 및 추적 관리의 향상을 목표로 한다. BD COR는 약 1,650건의 검사 용량을 제공하고 최대 24시간 내 1,000건의 결과를 산출하며; BD Viper LT는 소형의 분산형 분자 검사 서비스를 제공한다.
BD (NYSE: BDX) a annoncé que le test HPV BD Onclarity certifié CE pour les systèmes BD COR et BD Viper LT a obtenu la pré-qualification OMS le 17 novembre 2025, permettant une utilisation plus large dans les pays à revenu faible ou moyen.
Le test détecte 14 types HPV à haut risque avec une génotypage étendu (six types individuels plus trois groupes de génotypes), prend en charge l’auto-prélèvement, y compris à domicile lorsque le CE est reconnu, et vise à améliorer la stratification du risque et le suivi. Le BD COR offre une capacité d’environ 1 650 tests et jusqu’à 1 000 résultats en 24 heures; le BD Viper LT fournit des tests moléculaires compacts et décentralisés.
BD (NYSE: BDX) kündigte an, dass der CE-gekennzeichnete BD Onclarity HPV-Assay für die BD COR und BD Viper LT Systeme am 17. November 2025 die WHO-Vorqualifikation erhalten hat, was eine breitere Nutzung in Ländern mit niedrigem und mittlerem Einkommen ermöglicht.
Der Test erkennt 14 Hochrisiko-HPV-Typen mit erweiterter Genotypisierung (sechs einzelne Typen plus drei Genotyp-Gruppen), unterstützt Selbstabnahme, auch zu Hause dort, wo CE anerkannt ist, und zielt auf eine verbesserte Risikostratifizierung und Nachsorge ab. Der BD COR bietet ca. 1.650 Tests-Kapazität und bis zu 1.000 Ergebnisse in 24 Stunden; der BD Viper LT bietet kompaktes, dezentralisiertes molekulares Testen.
BD (NYSE: BDX) أعلنت أن اختبار HPV BD Onclarity المعتمد بموجب CE لآليتي BD COR و BD Viper LT تلقى الاعتماد المسبق من منظمة الصحة العالمية في 17 نوفمبر 2025، مما يتيح استخداماً أوسع في الدول منخفضة ومتوسطة الدخل.
يقوم الاختبار بالكشف عن 14 نوعاً من HPV عالي الخطورة مع تصنيف جيني موسع (ستة أنواع فردية بالإضافة إلى ثلاث مجموعات من الأنواع)، ويدعم الجمع الذاتي للعينات بما في ذلك في المنزل حيث يتم الاعتراف بال CE، ويهدف إلى تحسين التصنيف الخطر والمتابعة. يقدم BD COR قدرة ~1,650 اختبار وبحد أقصى 1,000 نتيجة في 24 ساعة؛ بينما يوفر BD Viper LT اختباراً جزيئاً مدمجاً ولامركزياً.
- WHO prequalification of CE-marked Onclarity expands access in low- and middle-income countries
- Assay detects 14 high-risk HPV types with extended genotyping
- Supports self-collection including at-home where CE mark is recognized
- BD COR capacity: nearly 1,650 tests and up to 1,000 results/24h
- BD Viper LT enables decentralized molecular testing in limited-resource labs
- WHO prequalification applies specifically to the EU CE-marked Onclarity assays
- In the U.S., self-collection approval is limited to healthcare settings, not at-home
Insights
WHO prequalification of the CE‑marked BD Onclarity™ assay expands validated HPV screening options for low‑ and middle‑income programs.
BD achieved WHO prequalification for the CE‑marked BD Onclarity™ HPV Assay for the BD COR™ and BD Viper™ LT systems on
The business mechanism is clear: prequalification enables procurement and use in public health programs in low‑ and middle‑income countries by meeting WHO procurement standards, which can increase demand for both the assay and supporting instruments. Key dependencies include national adoption decisions, procurement cycles, and recognition of the CE Mark in target countries. Watch for procurement awards, national screening policy updates, and rollout milestones over the next 6–24 months as indicators of tangible volume uptake.
RANKLIN LAKES, N.J., Nov. 17, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today 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."
The BD Onclarity™ HPV Assay is approved in the
The BD Viper™ LT System supports flexible testing in decentralized settings, offering a compact, benchtop design that enables molecular diagnostics in laboratories with limited space or infrastructure. It automates sample preparation and amplification, reducing manual steps and supporting consistent, reliable results. The system is designed for ease of use, with intuitive software and minimal hands-on time, making it well-suited for regional labs and public health screening programs where access to high-throughput platforms may be limited.
The BD COR™ System offers high-throughput automation for centralized laboratories, automating workflow with capacity for nearly 1,650 tests while delivering up to 1,000 sample results in 24 hours with barcode-driven traceability and remote system management. It offers up to seven hours of walk-away time, requires under 15 minutes to load, and uses room-temperature reagents that need no reconstitution, maximizing efficiency and minimizing manual interaction.
According to WHO, a woman dies of cervical cancer every 90 seconds. Cervical cancer is the fourth most common cancer in women worldwide, both in terms of 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.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson
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FAQ
What does WHO prequalification for BD Onclarity mean for BDX and global screening?
Which HPV types does the BD Onclarity assay detect on November 17, 2025?
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