FDA expands approval of BD Onclarity HPV assay
March 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test. The Onclarity HPV assay detects and identifies 14 high-risk human papillomavirus types in a single analysis. The assay reports genotypes 16, 18, 31, 45, 51, 52, 33/58, 35/39/68, and 56/59/66, and has FDA approval for use in vaccinated women.