Labcorp HPV testing is set to expand through a partnership with Waters Corporation announced on October 23, 2026. The companies intend to make the FDA-approved BD Onclarity HPV Assay available through Labcorp’s nationwide laboratory network beginning in late 2026, with clinician-collected and self-collected screening options.
Key Takeaways
- The companies target a late-2026 rollout; the announcement does not establish that testing has launched.
- Planned collection settings include clinics, patient service centers and patients’ homes.
- Labcorp will offer the testing through clinician programs, health plan initiatives and its OnDemand consumer channel.
Table of Contents
- Labcorp HPV testing expands collection options
- Extended genotyping provides more specific results
- Access goals remain separate from measured outcomes
- Conclusion
Labcorp HPV testing expands collection options
The partnership’s rollout plan covers both clinician-collected and self-collected screening across several settings. Labcorp intends to be the first commercial laboratory to offer the FDA-approved assay across that combination of collection options and locations.
The practical change is greater flexibility in where samples can be collected, rather than the introduction of a newly approved test. The announcement notes that self-collected vaginal specimens can be tested as an alternative when cervical sampling is contraindicated or cervical samples otherwise cannot be obtained.
Labcorp’s network serves more than 850,000 physicians and healthcare providers and includes more than 2,200 patient service centers. Those figures describe its existing reach, not confirmed participation at every location in the planned rollout.
| Item | Details |
|---|---|
| Assay | FDA-approved BD Onclarity HPV Assay |
| Individually identified HPV types | 16, 18, 31, 45, 51 and 52 |
| Other genotype reporting | Three pooled results covering eight additional high-risk HPV genotypes |
| Legal manufacturer during transition | Becton, Dickinson and Company or an affiliate or subsidiary remains the legal manufacturer pending required regulatory transfers to Waters. |
Extended genotyping provides more specific results
The BD Onclarity assay detects high-risk human papillomavirus strains linked to cervical cancer and provides extended genotyping. This distinguishes individual HPV types and groups, giving clinicians more specific information for assessing risk and managing positive results.
Waters says the assay supports all American Society for Colposcopy and Cervical Pathology Enduring Risk-Based Management Guidelines. Its individually identified types include HPV 16, 18 and 45, which the announcement identifies as associated with increased cervical cancer risk.
Access goals remain separate from measured outcomes
The companies aim to reach women who are overdue for screening by addressing barriers involving access, privacy and socioeconomic circumstances. Labcorp plans to incorporate the assay into its clinician programs, Gaps in Care health plan programs and Labcorp OnDemand.
The announcement did not quantify expected testing volumes, revenue contributions or patient uptake. Broader availability is the stated objective; improved screening participation and health outcomes remain anticipated benefits rather than demonstrated results of this partnership.
Conclusion
The next milestone is the intended late-2026 availability of the assay through Labcorp’s network. Confirmation of launch and the collection options actually offered will establish how the planned expansion translates into patient access.
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