BD Onclarity™ HPV Assay Receives FDA Approval for Use with Both BD SurePath™ Liquid-based Pap Test and Hologic ThinPrep® Pap Test
FRANKLIN LAKES, N.J., Feb. 21, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today 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 the two most common Pap vials used by laboratories in the United States.
- HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity™ HPV Assay is the only FDA-approved assay that screens for it individually."
- The BD Onclarity™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis.
- The ThinPrep® Pap Test with the BD Onclarity™ HPV Assay can be used on the BD COR™ or BD Viper™ LT instrument platforms without the need to change current cytology equipment.