Waters said its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay received FDA 510(k) clearance, enabling at-home collection to improve access to cervical cancer screening. The test covers all high-risk HPV genotypes and is processed on BD COR Systems. Waters worked with the National Cancer Institute’s Cervical Cancer “Last Mile” Initiative SHIP Trial to evaluate self-collection accuracy. The company said the test will be covered by Medicare, Medicaid and private insurers and is expected to be available by prescription in the near term. The kit can be mailed directly to patients, who collect samples at home and send them back for laboratory processing. Waters positioned the decision as a way to reduce screening drop-off by making it easier to complete recommended tests. Because the clearance concerns both an assay and the self-collection kit workflow, the update is likely to influence how health systems operationalize HPV screening and follow-up pathways.