BD submits pre-market approval supplement to enable use of pap test solution with HPV assay

Sept. 24, 2020

BD (Becton, Dickinson and Company) announced 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, according to a press release from BD.

The BD Onclarity Assay PMA supplement was submitted to the FDA to expand sample claims and platform usage.

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.

BD recently announced the FDA approval of a PMA supplement that included the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype results.

"This PMA supplement to the FDA signifies BD's commitment to expanding the availability of the BD Onclarity HPV Assay in the U.S. to support better patient management by providing clinicians more data to inform treatment decisions across multiple collection devices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "BD is dedicated to providing comprehensive screening solutions that are accessible globally in the fight to eliminate cervical cancer."

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