Waters Corporation has announced FDA clearance of the Onclarity HPV Self-Collection Kit alongside FDA approval of the BD Onclarity HPV Assay with extended genotyping for at-home use – enabling women to collect cervical cancer screening samples at home and mail them to a lab for processing.
The kit addresses a significant access gap: approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened, despite cervical cancer being largely preventable with regular HPV screening and early detection. Barriers to in-clinic screening – from scheduling and transportation to discomfort and stigma – have long kept millions of women from routine screening.
The Onclarity HPV Assay detects all high-risk carcinogenic HPV genotypes and identifies six individually and three in pooled groups, providing detailed genotyping alongside screening results. Waters collaborated with the NIH’s National Cancer Institute through the Cervical Cancer “Last Mile” Initiative SHIP Trial to evaluate self-collection accuracy.
“Expanding access to screening is one of the most important steps we can take to prevent cervical cancer, and at-home HPV self-collection is a game changer for making screening easier to complete,” said Jeff Andrews, MD, vice president of medical affairs at Waters Advanced Diagnostics. “When more patients are able to get screened, whether at home or in the clinic, clinicians have better information to identify risks earlier and intervene sooner.”
The kit is expected to be available by prescription in the coming months, covered by private insurance, Medicaid, and Medicare. It will be mailed directly to patients’ homes, with results shared with their healthcare provider to guide follow-up care. Waters is now establishing partnerships for broader nationwide distribution.
