Becton, Dickinson and Company (BD) , a global leader in medical technology, has submitted an application to the U.S. Food and Drug Administration (FDA) for its new at-home human papillomavirus (HPV) test. Designed to empower women with greater choice and access, the test allows users to self-collect a sample at home using a swab similar in size to a Q-tip. It is engineered for ease of use, lab compatibility, and advanced HPV detection.
"Our vision is to empower women to take control of their health—whether during a clinic visit or from the privacy of their own home," said Nikos Pavlidis, President of BD Diagnostic Solutions. "With over 4,000 preventable cervical cancer deaths in the U.S. each year, we believe at-home HPV screening is a vital step forward."
The test kit includes a simple, dry swab that does not require liquids or complex handling. It is stable enough for mailing to a lab, eliminating common logistical challenges and encouraging wider participation in cervical cancer screening.
Once received at the lab, the swab is processed on the BD COR™ System—a fully automated platform that uses robotics to handle sample preparation, analysis, and result reporting. This eliminates manual processing and reduces error, allowing lab professionals to focus on higher-value tasks. An internal cellular control ensures sample quality and test accuracy throughout the workflow.
The test uses the BD Onclarity™ HPV Assay, which identifies more high-risk HPV genotypes than any other test currently on the market. This is increasingly important as genotypes beyond HPV 16 and 18 are becoming more prevalent in cervical cancer cases.
A 2024 Harris Poll survey of over 1,100 U.S. women revealed that 72% have delayed gynecology visits, largely due to discomfort and inconvenience. Notably, 81% expressed a preference for less invasive HPV testing methods, and 74% showed interest in at-home vaginal self-swab testing.
The BD Onclarity™ Assay was recently included in the American Society for Colposcopy and Cervical Pathology (ASCCP)’s updated risk-based management guidelines for its expanded genotyping capabilities. Additionally, the U.S. Preventive Services Task Force (USPSTF) has included self-collection for HPV testing in its draft recommendations for preventive care.
With this FDA submission, BD aims to expand access to cervical cancer screening and move closer to eliminating a disease that remains both preventable and treatable when detected early.