Waters received FDA 510(k) clearance for its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay, enabling an at-home workflow for high-risk HPV screening. The test is designed to improve access to cervical cancer prevention by allowing patients to self-collect samples and mail them for laboratory processing. Waters evaluated accuracy with the National Cancer Institute’s Cervical Cancer “Last Mile” Initiative SHIP Trial, reflecting an effort to validate self-collection outside traditional clinic settings. The assay detects high-risk, carcinogenic HPV genotypes and is processed on BD COR Systems. Waters acquired the test through its $18.8 billion purchase of Becton Dickinson’s Biosciences & Diagnostic Solutions business. Waters says the test will be available by prescription in the near future and that coverage includes Medicare, Medicaid, and private insurers. The FDA clearance strengthens the patient-access case for mailing-based screening programs, which have been repeatedly targeted to close screening gaps.