Waters receives FDA clearance for at-home cervical cancer screening kit
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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
April 8, 2026 8:00 AM EDTFDA-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.3Waters is establishing partnerships to enable broader nationwide access to the Onclarity HPV Self-Collection Kit for patients and prescribers to reduce cervical cancer... More
