Waters Receives FDA Clearance for At-Home Cervical Cancer Screening Kit
核心洞察
Waters Corporation (搜索) announced FDA clearance of the Onclarity HPV Self-Collection Kit (搜索), marking a significant milestone in expanding access to cervical cancer (搜索) screening by removing barriers that prevent routine screening.
The kit utilizes the BD Onclarity HPV Assay (搜索), the most comprehensive FDA-approved HPV (搜索) screening tool in the U.S., which detects all high-risk carcinogenic HPV genotypes with extended genotyping capabilities.
Approximately 60% of cervical cancer (搜索) cases occur in individuals who are unscreened or under-screened, making at-home self-collection a critical strategy for improving early detection and reducing cervical cancer deaths.
Waters Corporation (搜索) announced that the U.S. Food and Drug Administration has cleared the Onclarity HPV Self-Collection Kit (搜索) and approved the BD Onclarity HPV Assay (搜索) with extended genotyping for at-home use. This regulatory milestone represents a significant advancement in expanding access to cervical cancer (搜索) screening and removing barriers that currently prevent many individuals from receiving routine screening.
Addressing Critical Screening Gaps
Cervical cancer (搜索) is largely preventable with regular screening and early detection of human papillomavirus (搜索) (HPV (搜索)), the virus responsible for nearly all cervical cancers. However, approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened. Public health experts have identified expanding screening options and access, including at-home self-collection, as an instrumental strategy for improving early detection and reducing cervical cancer deaths.
"Expanding access to screening is one of the most important steps we can take to prevent cervical cancer (搜索), and at-home HPV (搜索) 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. "As a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades, I have seen firsthand the profound difference early detection makes for patients."
Comprehensive HPV Detection Technology
The kit is tested with the BD Onclarity HPV Assay (搜索), which detects all of the high-risk, carcinogenic genotypes of HPV (搜索) 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 National Cancer Institute through the Cervical Cancer (搜索) 'Last Mile' Initiative SHIP Trial to evaluate the accuracy of self-collection for HPV (搜索) testing.
Market Access and Implementation
Waters is currently establishing partnerships to enable broader nationwide access to the Onclarity HPV Self-Collection Kit (搜索), which is expected to be available by prescription in the coming months. The kit is covered by private insurance, Medicaid, and Medicare, and 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.
"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," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics. "We're proud to provide this kit to advance earlier detection, achieve greater health equity, and ultimately reduce the burden of cervical cancer (搜索) for women and persons with a cervix."
The Onclarity HPV Self-Collection Kit (搜索), Onclarity HPV (搜索) Assay, and BD COR System are manufactured by Becton, Dickinson and Company or one of its affiliates or subsidiaries, following Waters Corporation (搜索)'s acquisition of BD's Biosciences and Diagnostic Solutions businesses.