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BD obtains FDA approval for cervical cancer screening self-collection kit

BD has received FDA approval for a kit enabling self-collection of specimens for human papillomavirus (HPV) testing, allowing individuals to collect vaginal specimens in healthcare settings when cervical samples are unavailable. This approval may facilitate self-sampling in non-traditional settings like retail pharmacies and mobile clinics, potentially improving screening accessibility. With nearly all cervical cancer cases being HPV positive, HPV screening is crucial for its elimination. In the U.S., 72% of women aged 21 to 65 were up-to-date with cervical cancer screening in 2021, with plans to increase this to over 84% by 2030. BD's Onclarity HPV Assay enables screening without a traditional Pap smear, enhancing convenience. While current approval permits self-collection in healthcare settings, BD sees potential for at-home self-collection, backed by a survey indicating 56% of U.S. women would feel comfortable with at-home cervical cancer screening, with two-thirds expressing interest in at-home HPV or cervical cancer screening.