BD, a global medical tech company, announced U.S. FDA market approval for the BD Onclarity HPV Assay to be used with the ThinPrep Pap Test.

The BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial are two common Pap vials used by laboratories in the United States. The inclusion of the ThinPrep Pap Test aims to improve access to the benefits of the BD human papillomavirus virus (HPV) assay, which is an FDA-approved assay that tests for an extended set of HPV types individually, and particularly for HPV31, a specific type of HPV that poses a high-risk for causing cervical cancer. Individual identification of HPV31 can help better determine risk for cervical pre-cancer, which may lead healthcare providers to different clinical decision-making than when assessing risk when multiple genotypes are reported collectively.

“Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer,” says Brooke Story, worldwide president of Integrated Diagnostics Solutions for BD. “Being able to identify high-risk HPV31 individually is critical to the detection and prevention of cervical cancer. 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.”

Further reading: Why Pap & HPV Cotesting Should Be Standard

This milestone supports BD’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. 

The BD Onclarity HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis. The assay reports genotypes beyond HPV types 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66, making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype results. The BD Onclarity HPV Assay has FDA approval for use in vaccinated women.

As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.

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. 

The BD COR System offers integrated and automated workflows, designed to free up time in the high-throughput laboratory, 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.  

Featured image: The BD Onclarity HPV Assay is the only FDA-approved assay that tests for an extended set of HPV types individually, including HPV 31, which poses a higher risk for causing cervical precancer than HPV 18. Photo: BD