BD Submits PMA Supplement To FDA For ThinPrep Pap Test PreservCyt Solution Vial - Quick Facts

(RTTNews) - Medical technology company Becton, Dickinson and Co. or BD (BDX) announced Wednesday that it has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the use of the ThinPrep Pap Test PreservCyt Solution vial as an approved sample type for its BD Onclarity HPV Assay.

The PMA supplement would expand the sample claims that can be used in addition to the BD SurePath vial for the detection of human papillomavirus (HPV) using the BD Onclarity HPV Assay.

The submission includes performance data for the BD Viper LT and the BD COR Systems. An additional supplement was submitted in January 2020 to seek approval for the BD Onclarity HPV assay on the BD COR System and the BD SurePath Liquid Based Cytology vial.

The BD Onclarity HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Collection Vial and in the Hologic PreservCyt Solution.

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