FDA Approves Use of BD’s HPV Assay with Pap Tests
Approval expands access to the HPV test that more precisely identifies risk for cervical cancer in patients
FRANKLIN LAKES, NJ — U.S. Food and Drug Administration approves BD (Becton, Dickinson and Company) Onclarity™ HPV Assay to be used with FDA-approved ThinPrep® Pap Test.
The inclusion of this test improves access to the benefits of the BD’s HPV assay—which is the only FDA-approved assay—that tests for an extended set of HPV types individually, particularly for HPV31, which poses a high risk for causing cervical cancer. Individual identification of HPV31 can help better determine the risk for cervical precancer. And this may differently drive clinical decision-making than when assessing risk with multiple genotypes collectively reported.
"Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer," said Brooke Story, BS, MBA, 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 precancer, and BD’s is the only FDA-approved assay that screens for it individually."
The BD 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, including types 31, 51, 52, 33/58, 35/39/68, and 56/59/66. It is FDA-approved for use in HPV-vaccinated women.
The evidence generation for the clinical validation of BD Onclarity™ HPV Assay was achieved by a study on a random selection of preserved samples from 19,879 women, who had undergone opportunistic cervical screening and follow-up in routine clinical practice, with known clinical outcomes.
"Cervical cancer is preventable," said Jeff Andrews, MD, FRCSC, 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."
- This press release was originally published on the BD (Becton, Dickinson and Company) website