BD Onclarity™ HPV Assay Receives FDA Approval for Use with Both BD SurePath™ Liquid-based Pap Test and Hologic ThinPrep® Pap Test
Expands Access to BD HPV Test that More Precisely Identifies Patients' Risk for Cervical Cancer
The BD SurePath™ Liquid-based
"Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer," said
This important 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 evidence generation for the clinical validation of BD Onclarity™ HPV Assay out of PreservCyt® media was achieved by one of the largest real-world evidence studies of its kind, conducted by Dr.
"Cervical cancer is preventable," said Dr.
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