BD received FDA approval for HPV test with extended genotyping capabilities
On Jul. 22, 2020, BD (Becton, Dickinson) announced that it had received approval for a pre-market approval (PMA) supplement from the 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.
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Source: Becton, Dickinson and Company
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