Health
Waters Announces FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay
Waters Corporation (NYSE: WAT) today 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.
About this update from Waters Corporation
[{"type":"list","items":[{"val":[{"type":"text","content":"FDA-approved BD Onclarity™ HPV Assay is the most comprehensive screening tool for HPV in the U.S.1,4 with extended genotyping and end-to-end automated lab workflows.","length":165,"tagName":"p"}]},{"val":[{"type":"text","content":"At-home self-collection reduces significant barriers for unscreened or under-screened individuals who make up approximately 60% of cervical cancer cases.3","length":154,"tagName":"p"}]},{"val":[{"type":"text","content":"Waters is establishing partnerships to enable broader nationwide access to the Onclarity™ HPV Self-Collection Kit for patients and prescribers to reduce cervical cancer risk.","length":174,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":493,"olType":false},{"type":"text","content":"MILFORD, Mass., April 8, 2026 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today 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.","length":456,"tagName":"p"},{"type":"image","alt":"Waters announces FDA clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening.","displaySize":"","headline":null,"caption":"Waters announces FDA clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening.","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":201,"url":"https://media.zenfs.com/en/prnewswire.com/27cae1318e3169fa56ae4226da8dd943"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/EDhlCiBpisWvIpzUeoqBAg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM1NA--/https://media.zenfs.com/en/prnewswire.com/27cae1318e3169fa56ae4226da8dd943","width":400,"height":201}},"href":"https://mma.prnewswire.com/media/2951757/Waters_Corporation_Onclarity_HPV_Self_Collection_Kit.html","hrefExternal":true,"rel":"nofollow"},{"type":"...