FDA Approves ARUP Laboratories’ AAV5 DetectCDx™, a First-Ever Companion Diagnostic Immunoassay for a Gene Therapy

FDA issues simultaneous approval of ROCTAVIAN™ (valoctocogene roxaparvovec-rvox), BioMarin’s gene therapy for severe hemophilia A. SALT LAKE CITY, June 29, 2023 /PRNewswire/ — ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDx™…