FDA approval granted to BD’s HPV assay for use with ThinPrep Pap Test
pharmafile | February 22, 2023 | News story | Medical Communications |
Becton, Dickinson and Company (BD) has received FDA approval for its new HPV assay which will be used in testing for human papillomavirus (HPV) alongside the ThinPrep Pap Test. The BD Onclarity HPV Assay is intended to detect 14 high-risk HPV types in one analysis.
The ThinPrep Pap Test was developed by health technology company, Hologic, and provides both Pap and HPV testing simultaneously with the same vial. Alongside BD SurePath liquid-based Pap test vial, Holohic ThinPrep Pap Test PreservCyt Solution is the most used vial in US laboratories, according to the company.
BD’s new assay is able to detect various HPV types, including: 16, 18, 45, 31, 51, 52, 33/58, 35/39/68 and 56/59/66.
BD has explained that its new assay is the only FDA approved assay to individually test for an extended set of HPV types, specifically HPV31, which has a high-risk for cervical cancer. Individual identification of HPV31 allows better identification of cervical pre-cancer, assisting healthcare providers in their decision-making processes.
Brooke Story, BD integrated diagnostics solutions worldwide president, commented: “Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer. […] 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.”
Jeff Andrews, BD medical affairs vice president, added: “Cervical cancer is preventable. 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 towards eliminating cervical cancer in our lifetimes.”
Betsy Goodfellow
