BD Onclarity HPV Assay receives FDA approval for use with both BD SurePath Liquid-based Pap Test and Hologic ThinPrep Pap Test

March 2, 2023
Expands access to BD HPV Test that more precisely identifies patients' risk for cervical cancer.

BD (Becton, Dickinson and Company) announced U.S. Food and Drug Administration (FDA) market approval for the BD Onclarity HPV Assay to be used with the ThinPrep Pap Test.

The BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial are two of the most common Pap vials used by laboratories in the United States. The inclusion of the ThinPrep Pap Test improves access to the benefits of the BD human papillomavirus virus (HPV) assay, which is an FDA-approved assay that tests for an extended set of HPV types individually, and particularly for HPV31, a specific type of HPV that poses a high-risk for causing cervical cancer. Individual identification of HPV31 can help better determine risk for cervical pre-cancer, which may lead health care providers to different clinical decision-making than when assessing risk when multiple genotypes are reported collectively.

The BD Onclarity HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis. The assay reports genotypes beyond HPV types 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66. The BD Onclarity HPV Assay has FDA approval for use in vaccinated women. As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.

BD release