US-based Labcorp, a global leader of innovative and comprehensive laboratory services, and Waters Corporation, a global life sciences and diagnostics leader, have announced a partnership to expand access to the FDA-approved BD Onclarity HPV Assay through Labcorp's nationwide laboratory network beginning in late 2026.
Cervical cancer is largely preventable through routine screening and early detection of human papillomavirus (HPV), yet millions of women remain overdue for recommended tests. This collaboration is designed to help address persistent cervical cancer screening gaps by bringing more accessible screening options to patients across the United States. Labcorp will provide these HPV testing options to support its clinician programmes, Gaps in Care health plan programmes, and Labcorp OnDemand consumer channel.
The BD Onclarity HPV Assay is the only FDA-approved HPV test that supports all American Society for Colposcopy and Cervical Pathology (ASCCP) Enduring Risk-Based Management Guidelines.
Certain HPV genotypes, including types 16, 18 and 45, are associated with an increased risk of cervical cancer, making genotype-specific information important for patient management. As HPV vaccination has reduced infections from HPV types 16 and 18, other high-risk HPV strains now account for a growing share of cervical disease, particularly among younger, vaccinated populations. The BD Onclarity HPV Assay offers extended genotyping that individually identifies HPV types 16, 18, 31, 45, 51 and 52 along with three sets of strategically pooled results, regardless of collection method, making it the most comprehensive HPV screening tool available in the US today.
