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

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.

Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus (HPV), the virus responsible for nearly all cervical cancers.2 Approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened.3 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.

“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.

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