Labcorp plans to offer the HPV test through clinician-collected and self-collected screening options beginning in late 2026, providing extended genotyping to help guide cervical cancer risk assessment.
Labcorp and Waters Corporation have entered into a partnership to expand access to the US Food and Drug Administration (FDA)-approved BD Onclarity HPV Assay across Labcorp’s nationwide laboratory network beginning in late 2026.
The initiative aims to address cervical cancer screening gaps throughout the US. Labcorp plans to make the test available through its clinician programs, Gaps in Care health plan initiatives, and the Labcorp OnDemand consumer channel.
“Barriers such as privacy, access, and socioeconomic factors can make it difficult to stay current with cervical cancer screening,” says Jeff Andrews, MD, FRCSC, vice president of medical affairs, Waters Advanced Diagnostics, Waters Corporation, in a release. “We are at the start of a new era in which screening can extend beyond the clinic, enable more personalized risk assessment, and reach people who have historically been underserved. By offering greater flexibility in how and where people are screened, our collaboration marks a critical step forward in bridging one of today’s most profound care gaps.”
Extended Genotyping and Guideline Alignment
The BD Onclarity HPV Assay is currently the only FDA-approved HPV test that supports all American Society for Colposcopy and Cervical Pathology Enduring Risk-Based Management Guidelines.
Clinical guidelines emphasize genotype-specific data because high-risk strains present varying levels of cervical cancer risk. Although HPV types 16, 18, and 45 carry the highest risk profile, widespread HPV vaccination has reduced the prevalence of types 16 and 18. Consequently, other high-risk strains are responsible for an increasing proportion of cervical disease, particularly among younger, vaccinated cohorts.
To address these shifts, the assay provides extended genotyping by individually identifying HPV types 16, 18, 31, 45, 51, and 52, while reporting three strategically pooled result groups across all validated collection methods.
“Cervical cancer screening saves lives, but too many women still face barriers to getting screened,” says Dr Brian Caveney, chief medical and scientific officer, Labcorp, in a release. “By expanding access and options for comprehensive FDA-approved HPV testing, we can help more women stay current with recommended screening, reach those who may be overdue for care, and support earlier identification of cervical cancer risk.”
The BD Onclarity HPV Assay is manufactured by Becton, Dickinson and Company. Waters Corporation has acquired the BD Biosciences and BD Diagnostic Solutions business units; however, BD remains the legal manufacturer and maintains regulatory responsibility for the platform until all formal regulatory transfers are completed.
Waters and Labcorp expect to roll out testing on the platform across the US by late 2026.
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