CLN Article

FDA Approves BD HPV Test for Cervical Cancer Screening

Regulatory Roundup: April 2018

BD has received approval from the Food and Drug Administration (FDA) for the BD Onclarity HPV assay. This test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers worldwide. In evaluating the BD Onclarity HPV assay, FDA reviewed data collected during a multi-year prospective, multi-center clinical trial conducted in the U.S. that included more than 33,500 women who either had or had not received the HPV vaccine. The test is clinically validated for use as a primary screening test, for triaging patients with abnormal Pap test results, and for use in combination with a Pap test. In future regulatory submissions, BD intends to seek approval for reporting of HPV types beyond 16, 18, and 45 consistent with the assay’s extended genotyping capabilities.

Advertisement
Advertisement