Posted by Michael Wonder on 30 Jun 2023
FDA approves ARUP Laboratories' AAV5 DetectCDx, a first-ever companion diagnostic immunoassay for a gene therapy
29 June 2023 - FDA issues simultaneous approval of Roctavian (valoctocogene roxaparvovec-rvox), BioMarin's gene therapy for severe haemophilia A.
ARUP Laboratories today announced that the US FDA has approved AAV5 DetectCDx as a companion diagnostic to aid in the selection of adult patients eligible for treatment with Roctavian (valoctocogene roxaparvovec-rvox).
