Sam Brusco, Associate Editor02.21.23
BD (Becton Dickinson) has earned U.S. Food and Drug Administration (FDA) approval for its Onclarity HPV (human papillomavirus) assay to be used with Hologic’s ThinPrep pap test.
According to the company, BD’s SurePath liquid-based pap test vial and Hologic’s ThinPrep pap test PreserveCyt solution vial are the two most common pap vials used by U.S. labs. Including the ThinPrep pap test increases access to BD’sHPV assay, the only FDA-approved assay that tests for an extended set of HPV types individually.
Particularly for HPV31, a type that has a high risk for causing cervical cancer. Identifying individual HPV31 can help determine cervical cancer risk.
"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 told the press. "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."
The Onclarity HPV assay detects and identifies 14 high-risk 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. It has approval for use in vaccinated women.
"Cervical cancer is preventable," said Dr. Jeff Andrews, vice president 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."
According to the company, BD’s SurePath liquid-based pap test vial and Hologic’s ThinPrep pap test PreserveCyt solution vial are the two most common pap vials used by U.S. labs. Including the ThinPrep pap test increases access to BD’sHPV assay, the only FDA-approved assay that tests for an extended set of HPV types individually.
Particularly for HPV31, a type that has a high risk for causing cervical cancer. Identifying individual HPV31 can help determine cervical cancer risk.
"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 told the press. "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."
The Onclarity HPV assay detects and identifies 14 high-risk 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. It has approval for use in vaccinated women.
"Cervical cancer is preventable," said Dr. Jeff Andrews, vice president 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."