NEW YORK – Becton Dickinson announced on Tuesday that its BD Onclarity human papillomavirus virus test has been approved by the US Food and Drug Administration for use with the Hologic ThinPrep Pap test.
The most common Pap test collection vials used by US labs are the BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial, BD said in a statement, noting that including ThinPrep in the clearance improves access to the benefits of the Onclarity test.
The BD Onclarity is an extended HPV typing test that detects 14 high-risk HPV types — HPV types 16, 18, and 45 as well as types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 — in a single analysis using multiplex real-time PCR.
The ThinPrep Pap Test with the BD Onclarity HPV Assay can be used on the BD Cor or BD Viper LT instrument platforms without the need to change current cytology equipment, BD said.
The BD Onclarity HPV test obtained premarket approval from the FDA in 2018 to run on the BD Viper LT system followed by supplemental PMA for extended genotyping to detect and distinguish 14 high-risk types of HPV in 2020. The BD Cor was approved by the FDA in 2021 along with the Onclarity HPV assay. The firm also obtained CE marking for the Onclarity HPV assay using samples collected at home and processed on the BD Viper or BD Cor.
BD noted that the BD Cor System offers integrated and automated workflows, and the extended claim for the BD Onclarity HPV Assay allows mid- to low-throughput labs to leverage the benchtop BD Viper LT instrument to enhance their HPV test offering.
"Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer," Brooke Story, worldwide president of Integrated Diagnostics Solutions for BD, said in a statement.
"Being able to identify high-risk HPV31 individually is critical to the detection and prevention of cervical cancer," Story noted, adding "HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity HPV Assay is the only FDA-approved assay that screens for it individually."
BD said the clearance is an important milestone supporting the firm's strategy "to penetrate the large and growing molecular diagnostics market through its expanded installed base and providing additional testing solutions for women's health."