Waters received FDA 510(k) clearance for its BD Onclarity HPV self-collection kit and assay, enabling an at-home screening workflow for high-risk HPV detection. The company said the cleared approach improves access by allowing patients to self-collect and mail samples for lab processing. The test, processed on the BD COR Systems platform, is intended to detect high-risk HPV genotypes associated with cervical cancer. Waters said the kit is covered by Medicare, Medicaid and private insurers and is expected to become available by prescription. The announcement lands in a broader push toward decentralized diagnostics, where ease of collection and improved screening completion are positioned as key levers for preventive care.