BD Advances At-Home HPV Testing with IVDR Certification and FDA Submission for Cervical Cancer Screening
Key Insights
BD (search) has received IVDR certification in Europe for its new at-home HPV (search) self-collection solution and submitted an FDA application for U.S. approval, aiming to expand access to cervical cancer (search) screening globally.
The innovative dry swab technology eliminates the need for liquids or complex devices, offers 30-day stability for convenient home-to-lab mailing, and requires no manual sample preparation at laboratories.
The BD Onclarity™ Assay (search) can detect more individual high-risk HPV (search) strains than any other available test, addressing the shifting prevalence of high-risk genotypes beyond HPV 16 (search)/18.
BD (search) (Becton, Dickinson and Company) has achieved a significant milestone in cervical cancer (search) screening with IVDR certification in Europe for its new at-home HPV (search) testing solution and submission of an FDA application for U.S. market approval. The medical technology company's innovation aims to address the critical need for expanded access to cervical cancer screening, particularly for underscreened populations who face barriers to traditional clinic-based testing.
Revolutionary Self-Collection Technology
The newly certified self-collection solution features a state-of-the-art swab technology that offers a safe, simple and non-invasive collection experience without requiring liquids or complex devices. The dry swab design provides exceptional stability, allowing samples to remain viable for 30 days, including up to 5 days at 45°C and 4 freeze/thaw cycles. This stability enables convenient mailing from home to laboratory facilities, effectively removing logistical barriers that often prevent participation in screening programs.
"This certification marks a meaningful advancement in our efforts to expand access to cervical cancer (search) screening around the world," said Nikos Pavlidis, worldwide president of BD (search) Diagnostic Solutions. "By enabling fully automated processing of self-collected samples, we're helping laboratories improve efficiency while making it easier for underscreened persons to participate in screening programs from the comfort of their homes."
Automated Laboratory Processing
The innovation extends beyond sample collection to laboratory processing through integration with the BD COR™ System (search). Once a self-collected swab arrives at the laboratory, it requires no manual sample preparation by clinical laboratory technologists, allowing them to focus on higher-value tasks. The system employs sophisticated robotics to prepare, analyze and report results through a fully automated process that includes onboard rehydration technology.
The unified, barcode-driven workflow accommodates both clinician-collected and self-collected samples, utilizing the proven performance of the Copan FLOQSwab® (search). An internal cellular control system, combined with minimal manual intervention, helps ensure specimen integrity from collection through delivery of results.
Enhanced HPV Detection Capabilities
The BD Onclarity™ Assay (search) represents a significant advancement in HPV (search) detection, capable of identifying more individual high-risk HPV strains than any other test currently available. This enhanced detection capability addresses the shifting prevalence of high-risk genotypes beyond the traditionally monitored HPV 16 (search)/18 strains. The American Society for Colposcopy and Cervical Pathology (search) (ASCCP (search)) has added the BD Onclarity™ Assay to its Enduring Risk-Based Management Guidelines due to this expanded detection capability.
Addressing Patient Preferences and Barriers
The development responds to significant patient demand for alternative screening options. A November 2024 survey conducted by the Harris Poll (search) of more than 1,100 U.S. women revealed that 72% have delayed gynecology visits, highlighting the need for greater convenience and comfort in cervical cancer (search) screening processes. The survey found that 81% of women desire more comfortable and less invasive HPV (search) testing options compared to traditional pelvic examinations, with 74% expressing interest in using self-collection vaginal swab tests at home.
"We envision a world where women are empowered with access and a choice for their HPV (search) screening, whether it be in a routine visit at the doctor's office or the comfort and privacy of their own home via a self-collected sample," said Pavlidis. "Cervical cancer (search) and the loss of more than 4,000 women per year to this devastating disease is preventable, and we believe at-home testing is an important leap forward to our goal of eliminating this type of cancer."
Market Availability and Regulatory Support
The BD (search) Onclarity™ HPV (search) Self-Collection with Onboard Rehydration Fully Automated Solution is expected to become commercially available across IVDR-recognized markets in the coming months. The IVDR certification in Europe is recognized by many countries worldwide, potentially expanding global access to this screening technology.
Self-collection for HPV (search)/cervical cancer (search) screening aligns with draft recommendations from the U.S. Preventive Services Task Force (search) (USPSTF (search)), which provides guidance to healthcare providers about effective preventive care services. The regulatory support underscores the growing recognition of self-collection as a viable strategy for improving screening participation rates and reducing cervical cancer incidence.