BD Aiming to Improve Cervical Cancer Screening

BD (Becton, Dickinson and Company) has submitted an application to the U.S. Food and Drug Administration for a new, at-home human papillomavirus (HPV) test that enables patients to self-collect a sample in their own home using a Q-tip sized swab that simplifies lab processing and reports more high-risk HPV strains than other assays.

“We envision a world where women are empowered with access and a choice for their HPV 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,” BD Diagnostic Solutions President Nikos Pavlidis said. “Cervical cancer 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.”

When available, the new HPV test from BD will include a state-of-the-art self-collection swab technology that offers a safe, simple and non-invasive collection experience without the need for liquids or complex devices. The swab’s stability also allows for convenient mailing from home to lab, removing logistical barriers and supporting broader participation in cervical cancer screening programs.

At the lab, the self-collected swab needs no manual sample preparation by clinical laboratory technologists, which allows them to focus on higher value work. The sample is simply placed into the BD COR System and the fully automated process uses sophisticated robotics to prepare, analyze and report results for each sample. Using an internal cellular control and minimizing manual touch and intervention ensures the integrity of the specimen from collection to delivery of dependable, high-quality results.

Importantly, the BD Onclarity Assay can also report more individual high-risk HPV strains than any other currently available test, according to BD.

In November 2024, a survey of more than 1,100 U.S. women conducted online by the Harris Poll found that 72% of females have delayed a gynecology visit, with many highlighting the need for greater convenience, comfort, and ease for this critical cervical cancer screening process. The study also found that 81% of women want more comfortable and less invasive HPV/cervical cancer testing options versus a pelvic exam, with 74% indicating interest in using a self-collection vaginal swab test at home in place of going to an office or clinic where a doctor uses a speculum to collect a sample from their cervix.

Earlier this year, the American Society for Colposcopy and Cervical Pathology (ASCCP) added the BD Onclarity Assay to its Enduring Risk-Based Management Guidelines, due to its ability to individually identify more high-risk HPV types. Self-collection for HPV/cervical cancer screening is also among the draft recommendations by the U.S. Preventive Services Task Force (USPSTF), which helps guide healthcare providers in the U.S. about the effectiveness of specific preventive care services to improve the health of people nationwide.

BD is one of the world’s largest global medical technology companies and is advancing health by improving medical discovery, diagnostics, and care delivery. The company develops technologies, services, and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD’s more than 70,000 employees 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 worldwide to address some of the most challenging global health issues.