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# BD Expanded HPV Assay Approved
- URL: https://www.fdaweb.com/bd-expanded-hpv-assay-approved/
- Published: 2020-07-22T12:00:00.000Z
- Updated: 2026-09-14T16:22:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147260

FDA has approved a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay. The submission includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 genotypes. The company says that the need for expanded HPV genotyping for cervical screening has been recognized since 2016, and that the expanded screening test result “could improve risk stratification and support risk-based patient management.”

The assay detects and identifies 14 high-risk HPV types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Collection Vial, BD says. It is approved for clinical use in cytology-based screening with ASC-US triage, in co-testing paradigm, and in primary HPV screening, the company says.