BD Onclarity™ HPV Assay Receives WHO Prequalification
BD (Becton, Dickinson and Company), a prominent entity in medical technology, has announced a significant milestone for its Onclarity™ HPV Assay. This diagnostic tool, which is compatible with both the BD COR™ System and the BD Viper™ LT System, has now received prequalification from the World Health Organization (WHO). This recognition is pivotal in expanding access to effective cervical cancer screening, especially in low- and middle-income countries where resources are often limited.
Expanding Access to Essential Screening Tools
The WHO prequalification allows the BD Onclarity™ HPV Assay to be recognized as a high-quality in vitro diagnostic product. It can now be incorporated into cervical cancer screening initiatives across various regions that struggle with healthcare access. With the capability to detect 14 high-risk HPV types, the assay includes advanced genotyping that identifies individual HPV types, assisting healthcare providers in stratifying risk more accurately. This innovation allows for optimized patient management, enabling better follow-up care for those identified as high-risk and reducing unnecessary procedures for those with low-risk results.
Self-Collection for Accessibility
Notably, the BD Onclarity™ HPV Assay includes an approval for self-collection, granting women the ability to handle samples from home in countries acknowledging the CE mark. This feature significantly increases accessibility to vital screening, bridging gaps for those in remote areas or with limited healthcare facilities. By offering various collection and testing modes, BD is ensuring that significant advancements in cervical cancer screening are available to those who need them most.
Transforming Cervical Cancer Screening
In a statement, Nikos Pavlidis, worldwide president of Diagnostic Solutions at BD, emphasized the importance of this prequalification. He noted that cervical cancer, a preventable disease, poses a major public health crisis globally, with a woman dying from this illness every 90 seconds. BD’s efforts in enhancing access to quality diagnostic tools play a crucial role in bolstering global health initiatives aimed at eliminating cervical cancer.
The Tools Behind the Solution
The BD Viper™ LT System is designed to facilitate flexible testing, standing out for its compact design that fits laboratories with limited space, and automates sample processing, aligning with the needs of regional healthcare settings. Meanwhile, the BD COR™ System boasts high-throughput capabilities, automating workflows to manage nearly 1,650 tests and producing results rapidly, thus maximizing efficiency in centralized laboratory environments.
Both systems underline BD’s commitment to advancing healthcare quality and efficiency, fostering environments where high-capacity diagnostics can thrive.
Leading the Charge Against Cervical Cancer
Both tools align with global movements towards prioritizing primary HPV screening, reinforcing WHO guidelines advocating for self-collection and advanced genotyping. BD’s WHO prequalification indicates that their assays meet strict global standards for safety and performance, ensuring that cervical cancer screening programs around the world can rely on these important diagnostics.
About BD
BD stands as a beacon in the medical technology landscape, with a mission dedicated to advancing health worldwide. Comprising over 70,000 employees, the company delivers innovative solutions that enhance clinical care and laboratory diagnostics, significantly impacting patient outcomes. Collaborations with global partners further underscore BD's commitment to addressing complex health challenges and improving healthcare access worldwide. Learn more about BD and its initiatives by visiting
bd.com.