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Waters and Labcorp to Expand Access to Cervical Cancer Screening with the Most Comprehensive FDA-Approved HPV Testing Option Beginning in Late 2026

  • Labcorp & Waters Corporation announced a partnership to expand access to the FDA-approved BD Onclarity HPV Assay starting in late 2026.
  • Labcorp will become the first commercial laboratory to offer this test across clinician-collected, patient service center, & at-home settings.
  • The BD Onclarity HPV Assay is the only FDA-approved HPV test that supports all ASCCP Enduring Risk-Based Management Guidelines.
  • The assay provides comprehensive extended genotyping by individually identifying HPV types 16, 18, 31, 45, 51, & 52.
  • Labcorp's network serving over 850,000 physicians & 2,200 patient service centers will be used to reduce cervical cancer screening gaps.
  • The collaboration aims to address barriers such as privacy, access, & socioeconomic factors that prevent women from receiving recommended screenings.
  • Extended genotyping is critical as other high-risk HPV strains now account for a growing share of cervical disease among vaccinated populations.
  • Waters Corporation acquired the BD Biosciences & BD Diagnostic Solutions businesses, though BD remains the legal manufacturer during regulatory transfers.