Waters Corporation 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. Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus (HPV), the virus responsible for nearly all cervical cancers. Approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened.
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, making it the most comprehensive HPV screening tool available in the U.S. today. 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. The Onclarity HPV Self-Collection Kit, Onclarity HPV Assay, and BD COR System are manufactured by Becton, Dickinson and Company or one of its affiliates or subsidiaries.
