• 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.
  • At-home self-collection reduces significant barriers for unscreened or under-screened individuals who make up approximately 60% of cervical cancer cases.3
  • 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.

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.