Becton Dickinson annoucnes FDA approval of new HPV test
BD announced that it has received pre-market approval from the FDA for the BD Onclarity HPV assay. The test detects 14 types of high-risk human papillomavirus, or HPV, from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The BD Onclarity HPV assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers worldwide, and are disproportionally responsible for up to 94 percent of glandular cervical cancer cases. In evaluating the test, the FDA reviewed data collected during a multi-year, prospective, multi-center clinical trial conducted in the US that included more than 33,500 vaccinated and non- vaccinated women. The BD Onclarity HPV assay may be used in accordance with clinical guidelines for cervical cancer screening and management to identify the presence of high-risk HPV types. The test is clinically validated for use as a primary screening test, for triaging patients with abnormal Pap test results and to be used in combination with a Pap test. The BD Onclarity HPV assay provides information that together with the physician's assessment and professional guidelines, may be used to inform clinical decision-making. BD intends to seek approval in future submissions for reporting of HPV types beyond 16, 18 and 45 consistent with the extended genotyping capabilities of the assay's design and aligned with evolving cervical cancer screening guidelines.