New automated workflow combines at-home sampling with robotic lab processing.
BD has received In Vitro Diagnostic Medical Device Regulation (IVDR) certification in Europe for a new HPV self-collection solution designed to broaden access to cervical cancer screening in international markets.
The IVDR-certified workflow combines simplified at-home sample collection with fully automated laboratory processing through the BD COR System. The technology is recognized by many countries worldwide and will become commercially available across IVDR-recognized markets in the coming months.
The self-collection swab requires no liquids or complex devices and offers stability for convenient mailing from home to laboratory. This design aims to remove logistical barriers and support broader participation in cervical cancer screening programs, particularly for underscreened populations.
Automated Lab Processing Reduces Manual Steps
At the laboratory level, the self-collected swab requires no manual sample preparation by clinical laboratory technologists. Once placed into the BD COR System, sophisticated robotics handle the entire process of sample preparation, analysis, and result reporting.
The workflow incorporates an internal cellular control combined with minimal manual intervention to help ensure specimen integrity from collection through result delivery. This automation allows laboratory staff to focus on higher-value tasks while maintaining quality standards.
“This certification marks a meaningful advancement in our efforts to expand access to cervical cancer screening around the world,” says Nikos Pavlidis, worldwide president of BD Diagnostic Solutions, in a release. “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.”
Key Workflow Features
The BD Onclarity HPV Self-Collection with Onboard Rehydration Fully Automated Solution includes several technical components designed for both patient convenience and laboratory efficiency. The system maintains sample stability during transport and processing while providing automated quality controls throughout the testing workflow.
The certification comes as healthcare systems globally seek to improve cervical cancer screening rates, particularly in populations with limited access to traditional clinical settings. Self-collection methods have shown promise in increasing participation rates among women who might otherwise avoid screening.
BD’s solution addresses both patient accessibility and laboratory operational challenges by combining user-friendly collection methods with high-throughput automated processing capabilities.
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