Waters received FDA 510(k) clearance for the BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay, enabling HPV screening through at-home specimen collection. The company said the approach is intended to expand access to testing for high-risk HPV genotypes that drive most cervical cancers. Waters stated the kit was evaluated with the National Cancer Institute’s Cervical Cancer “Last Mile” Initiative SHIP trial, supporting claims around accuracy of self-collection. The assay is processed on BD COR Systems and is expected to be available by prescription soon. Waters also noted the assay will be covered by Medicare, Medicaid, and private insurers, with patients able to mail samples to laboratories. The clearance follows Waters’ acquisition of Becton Dickinson’s Biosciences & Diagnostics business for $18.8 billion, bringing additional momentum to home-based oncology screening workflows.