The BD Onclarity™ HPV Assay enhances cervical cancer screening by individually identifying six high-risk HPV types and detecting an additional 8 genotypes, reported in 3 strategically-grouped pools, providing a more accurate risk assessment for CIN3+. It is now included in ASCCP guidelines, with results categorized into three risk tiers to guide patient management. This innovative approach aims to improve screening and contribute to the goal of eliminating cervical cancer.
Empower clinicians with HPV extended genotyping results. The BD Onclarity™ HPV Assay stands out as:
- The only FDA-approved HPV test that is supported by all ASCCP extended genotyping guidelines for guiding the management of positive HPV results*1
- The only test with extended genotyping beyond 16, 18 and 45 approved for use with in-clinic patient-collected vaginal swabs, potentially expanding access to cervical screening for more patients#2,3
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*There are currently two FDA-approved HPV tests with extended genotyping with different configurations. The BD Onclarity™ HPV Assay was the only FDA-approved test with extended genotyping when the evidence review for the extended genotyping guidelines started, thus rendering the guidelines tailored specifically to the BD Onclarity™ HPV Assay.1
# Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
1. Massad LS, Clarke MA, Perkins RB, et al. Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines. Journal of Lower Genital Tract Disease. Published online January 10, 2025
2.BD Onclarity™ HPV Assay US Package Insert [8089894].
3.Wentzensen, Nicolas MD, PhD1; Massad, L. Stewart MD2, Clarke, Megan A. PhD1, et al. Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Self-Collected Vaginal Specimens for HPV Testing: Recommendations From the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. Journal of Lower Genital Tract Disease. 29(2):p 144-152, April 2025. | DOI: 10.1097/LGT.0000000000000885.
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