BD Receives FDA Supplemental Premarket Approval for Extended Genotyping HPV MDx

NEW YORK – Becton Dickinson announced Wednesday that the US Food and Drug Administration has issued a premarket approval supplement for its expanded human papillomavirus assay. The BD Onclarity HPV Assay is now the only FDA-approved test to individually identify and report genotype results in addition to the standard high-risk genotypes 16, 18, and 45, the firm said in a statement.