Primary Human Papillomavirus Screening for Cervical Cancer in the United States-US Food and Drug Administration Approval, Clinical Trials, and Where We Are Today

The US Food and Drug Administration recently approved the additional indication of Primary Screening for the Roche cobas human papillomavirus test. This commentary includes an overview of the supporting clinical trial data, issues this approval will present for laboratorians, and proposed clinical management guidelines for abnormal screening results.