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Medical Devices / Submissions and Approvals

FDA Approves Becton Dickinson HPV Assay

Feb. 15, 2018
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The FDA granted premarket approval to Becton Dickinson for its BD Onclarity HPV assay.

The assay is performed on the company’s molecular platform for automated sample processing for the detection of high-risk HPV using samples from cervical cancer screening using the BD SurePath liquid-based cytology vial.

It is also designed to provide information to aid in clinical decision-making. The company said it intends to pursue FDA approval to expand on the assay’s genotyping capabilities.

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