The ThinPrep Pap test, developed by Hologic (Nasaq:HOLX), offers Pap and HPV testing from one vial. It accompanies the BD SurePath liquid-based Pap test vial as the most commonly used vials by labs in the U.S.
BD said in a news release that including ThinPrep in its testing offerings improves access to the benefits of its human papillomavirus virus (HPV) assay. That assay has approval for an extended set of HPV types. This includes HPV31, which poses a high risk for causing cervical cancer. In total, it detects and identifies 14 high-risk HPV types in a single analysis.
“Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer,” said 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.”
More on the BD HPV assay approval
BD said the approval supports its strategy to penetrate the growing molecular diagnostics market. The company now offers an expanded installed base with additional women’s health testing solutions.
The BD Onclarity HPV assay has FDA approval for use in vaccinated women. Data for the approval came from one of the largest real-world evidence studies of its kind, BD said. It included 19,879 women’s preserved samples. Those women underwent opportunistic cervical screening and follow-up in routine clinical practice with known clinical outcomes.
The newly approved assay can be used on the BD Cor or BD Viper LT instrument platforms. It doesn’t require changing the current cytology equipment.
“Cervical cancer is preventable,” said Dr. Jeff Andrews, VP of medical affairs for BD. “When more people with a cervix are better able to manage their health through more accurate and precise testing, we are taking another step forward toward eliminating cervical cancer in our lifetimes.”