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Becton Dickinson Submits Premarket Approval Supplement to FDA for HPV Assay

NEW YORK – Becton Dickinson announced on Wednesday that it has submitted a premarket approval supplement to the US Food and Drug Administration to enable the use of the ThinPrep Pap Test PreservCyt Solution vial with its BD Onclarity HPV Assay.

The firm's Onclarity human papillomavirus assay is a PCR-based test that detects and distinguishes 14 high-risk human papillomavirus types. It received pre-market approval from the FDA in 2018 for cervical cancer screening samples collected in the BD SurePath collection vial. The assay is authorized for clinical use in cytology-based screening with ASC-US triage, in cotesting paradigms, and in primary HPV screening, including for use in women who have received the HPV vaccine.

"This PMA supplement to the FDA signifies BD's commitment to expanding the availability of the BD Onclarity HPV Assay in the US 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 received approval in July for 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. The BD Onclarity HPV Assay is currently the only FDA-approved assay to individually identify and report these genotype results, the firm said.

An additional supplement was submitted in January to seek approval for the BD Onclarity HPV assay on the BD COR System and the BD SurePath Liquid Based Cytology vial, and the PMA supplement for ThinPrep PreservCyt includes performance data for the BD Viper LT and the BD COR Systems, the firm noted.

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