NEW FDA Cleared Onclarity™ Self‑Collection Kit for At-Home Use
More patient options. Clinician-directed care.
An at‑home self‑collection kit designed to meet patients where they are — while keeping clinicians anchored in innovation with the BD Onclarity™ HPV testing with extended genotyping for risk-based patient management. BD Onclarity™ HPV Assay the only FDA approved HPV test today with the ability to give results aligning with all ASCCP Enduring Risk-Based Management Guidelines for cervical cancer screening. 1,2
More ways to collect.
The BD Onclarity™ HPV Assay supports both cervical specimen
collection and self‑collection options (in-clinic and at-home).
BD Onclarity™ HPV Assay is the only FDA-approved HPV test that supports all of the ASCCP Enduring Risk-Based Management Guidelines3, offering the most individual genotypes† and providing flexible collection options2.
Learn more about BD Onclarity™ →
Results that matter — for every test decision.
Clinicians: Ask your labs for more than three HPV results – ask for BD Onclarity™ HPV Assay by name.
Patients: Ask your provider for the BD Onclarity™ HPV Assay at your next screening visit.
References
*Self-collected vaginal specimens can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
†The BD Onclarity HPV Assay is the only FDA-approved HPV test which provides the capability for individually genotyping six high-risk types and three genotype groups.
- FDA Press release
- BD Onclarity™ HPV Assay US Package Insert [8089894]
- ASCCP. Management Guidelines and the Enduring Guidelines Process. Accessed February 2025.
- Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
- Stoler MH et al. Gynecol. Oncol. 2019; 153(1):26–33.