Posted by Michael Wonder on 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to determine patient eligibility for treatment with Beqvez (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA approved haemophilia B gene therapy.
The nAbCyte cell-based neutralising antibody assay is a component of Pfizer's program to target recombinant adeno-associated virus (rAAV)-based gene therapies to the appropriate patient population. Before infusion with Beqvez, patients will require testing for preexisting anti-AAVRh74var antibodies.
