July 22, 2020 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity HPV Assay.
The PMA supplement includes 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 genotypes making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype results.
“With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the United States and other countries recognizing the PMA supplement or CE mark,” said Dave Hickey, president, Integrated Diagnostic Solutions at BD. “Our goal is to continue the global fight towards eliminating diseases and associated deaths due to cervical cancer with our comprehensive diagnostic solutions.”