Waters said its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay received 510(k) clearance from the FDA. The company positioned at-home self-collection as a way to improve access to screening for high-risk HPV genotypes associated with cervical cancer. Waters said the kit is processed on BD COR Systems and was evaluated for accuracy through the National Cancer Institute’s Cervical Cancer “Last Mile” Initiative SHIP Trial. The company added that the test is covered by Medicare, Medicaid and private insurers and is expected to be available by prescription soon. By enabling mailed sampling, the platform targets patients who have fallen behind on screening and aims to shorten the time from collection to clinician follow-up, with implications for prevention workflows in oncology and primary care.