CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
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.
The ThinPrep Pap test with the Onclarity HPV assay can be used on the BD Cor or BD Viper LT instrument platforms without the need to change current cytology equipment, the company says.
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