Becton, Dickinson and Company (BD) has received market approval from the US Food and Drug Administration (FDA) for its Onclarity HPV Assay for use with the ThinPrep Pap Test.
The BD Onclarity HPV Assay has been designed to detect and identify 14 high-risk human papillomavirus (HPV) types in a single analysis.
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In addition to HPV types 16, 18, and 45, the test also reports genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66.
The company claimed that Onclarity is the only FDA-approved assay that can individually test an extended set of HPV types, specifically HPV31, which poses a high risk for cervical cancer.
It also noted that individual detection of HPV31 enables better identification of risk for cervical pre-cancer. This helps healthcare providers with their clinical decision-making.
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The ThinPrep Pap test, developed by Hologic, offers both Pap and HPV testing using the ONE vial.
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By GlobalDataThe BD SurePath liquid-based Pap test vial and Hologic ThinPrep Pap Test PreservCyt Solution vial are said to be the most used vials by US laboratories, according to the company.
BD Integrated Diagnostics Solutions worldwide president Brooke Story said: “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.”
The US FDA approved the BD Onclarity HPV Assay for use in vaccinated people.
The company stated that the ThinPrep Pap Test along with the BD Onclarity HPV Assay can be used on the BD COR or BD Viper LT instrument platforms, without requiring changes to existing cytology equipment.
BD medical affairs vice-president Dr Jeff Andrews said: “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 toward eliminating cervical cancer in our lifetimes.”
