NEW YORK — Becton Dickinson said on Tuesday that it has submitted a premarket approval (PMA) supplement to the US Food and Drug Administration for an expanded version of its Onclarity human papilloma virus (HPV) assay.
The test, which received premarket approval in early 2018, detects DNA from 14 high-risk HPV types using specimens collected in the company's SurePath liquid-based cytology vial for cervical cancer screening. According to BD, it is the only FDA-approved assay to individually identify and report HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers and glandular cervical precancer cases.
BD said that the supplement is seeking premarket approval for genotype reporting for 11 additional types including 31, 51, and 52. The FDA submission includes data from a three-year follow up of subjects in a multicenter, prospective clinical trial of over 33,500 women including those who received HPV vaccines and those who did not.
"This PMA submission is the next step in our roadmap for the BD women's health and cancer portfolio as it brings us one step closer to expanding access to extended HPV genotyping capabilities in the US market," Dave Hickey, president of BD Integrated Diagnostic Solutions, said in a statement.