CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
August 2023—ARUP Laboratories announced that the FDA approved AAV5 DetectCDx as a companion diagnostic to aid in the selection of adult patients eligible for treatment with Roctavian (valoctocogene roxaparvovec-rvox). Roctavian, a gene therapy developed by BioMarin Pharmaceutical, received contemporaneous FDA approval for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with FVIII activity <1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.
AAV5 DetectCDx is a single-site assay performed at ARUP Laboratories.
ARUP Laboratories, 801-583-2787