Waters announces FDA clearance of the Onclarity HPV Self-Collection Kit and FDA-approved HPV Assay
At-home self-collection reduces significant barriers for unscreened or under-screened individuals
17 Apr 2026
Waters Corporation has announced that the U.S. Food and Drug Administration (FDA) has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening, and removing barriers that currently prevent many individuals from receiving routine screening.
Expanding screening options and access, including at-home self-collection, has been identified by public health experts as an instrumental strategy for improving early detection and reducing cervical cancer deaths.
The kit is tested with the BD Onclarity HPV Assay, which detects all of the high-risk, carcinogenic genotypes of HPV and is the only FDA-approved HPV assay to identify six individually and three groups of pooled results. Samples are processed on the fully automated BD COR™ System, which uses advanced robotics to prepare, analyze, and report results while preserving specimen integrity and ensuring reliable, high-quality outcomes.
Waters collaborated with the National Institutes of Health's (NIH) National Cancer Institute (NCI) through the Cervical Cancer 'Last Mile' Initiative SHIP Trial to evaluate the accuracy of self-collection for HPV testing.
Waters is currently establishing partnerships to enable broader nationwide access to the Onclarity HPV Self-Collection Kit, which is expected to be available by prescription in the coming months.
Covered by private insurance, Medicaid, and Medicare, the kit can be mailed directly to a patient's home, allowing them to collect a sample at their convenience and mail it to a laboratory for processing. Results are shared with the patient's healthcare provider to guide follow-up and care decisions.
"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, M.D., FRCSC, Vice President of Medical Affairs, Waters Advanced Diagnostics, Waters Corporation.
"As a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades, I have seen first hand the profound difference early detection makes for patients. 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. That allows us to spend less time trying to reach patients who have fallen behind on screening and more time focusing on prevention, follow-up care, and treatment for those who need it."
Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation, added, "U.S. FDA clearance of the Onclarity Self-Collection Kit for at-home use marks a meaningful step towards removing today's primary barriers to screening, and supporting more personalized care. We're proud to provide this kit to advance earlier detection, achieve greater health equity, and ultimately reduce the burden of cervical cancer for women and persons with a cervix."