FDA Panel Recommends New Studies For Fujirebio’s Ovarian Cancer Test
This article was originally published in The Gray Sheet
Executive Summary
FDA should not clear Fujirebio's HE4 enzyme immunoassay kit and associated "risk of ovarian malignancy algorithm"(ROMA) until the firm demonstrates the test's ability to help community physicians triage patients for referral to gynecologic oncology specialists, according to the agency's Immunology Devices advisory panel