Core Insights - BD has submitted an application to the U.S. FDA for a new at-home HPV test that allows self-collection of samples, utilizing a Q-tip-sized swab that simplifies lab processing and reports more high-risk HPV strains than any other test available [1][2]. Group 1: Product Features and Benefits - The new HPV test includes a self-collection swab technology that is safe, simple, and non-invasive, eliminating the need for liquids or complex devices, and facilitating convenient mailing from home to the lab [3]. - The BD Onclarity™ Assay can report more individual high-risk strains of HPV than any other test, addressing the changing prevalence of high-risk genotypes beyond HPV 16/18 [5]. - The self-collected swab requires no manual sample preparation, allowing laboratory technologists to focus on higher-value work, and ensures specimen integrity from collection to result reporting [4]. Group 2: Market Demand and Trends - A survey by Harris Poll indicated that 72% of U.S. women have delayed gynecology visits, with 81% preferring more comfortable and less invasive testing options, and 74% showing interest in self-collection tests at home [6]. - The American Society for Colposcopy and Cervical Pathology has included the BD Onclarity™ Assay in its guidelines due to its ability to identify more high-risk HPV types, and self-collection is also recommended in draft guidelines by the U.S. Preventive Services Task Force [7]. Group 3: Company Overview - BD is one of the largest global medical technology companies, focused on improving medical discovery, diagnostics, and care delivery, with a commitment to enhancing safety and efficiency in healthcare [8].