Waters received FDA 510(k) clearance for the BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay, enabling at-home self-collection for high-risk HPV screening. The company said the clearance is intended to improve access to testing for populations that may face barriers to clinic-based sampling. Waters also cited evaluation work with the National Cancer Institute’s Cervical Cancer “Last Mile” Initiative SHIP Trial. The test is expected to be available by prescription and processed through BD COR Systems; Waters noted the assay detects high-risk, carcinogenic HPV genotypes. With screening covered by Medicare, Medicaid, and private insurers, the device clearance broadens the diagnostic pathway for cervical cancer prevention and could reduce missed screenings tied to access constraints.