Labcorp: FDA approves nAbCyte Anti-AAVRh74var HB-FE Assay

Labcorp (LH) 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, Pfizer’s (PFE) recently FDA-approved hemophilia B gene therapy. The nAbCyte cell-based neutralizing antibody assay is a component of Pfizer’s program to target recombinant adeno-associated virus-based gene therapies to the appropriate patient population. Before infusion with BEQVEZ, patients will require testing for preexisting anti-AAVRh74var antibodies. Labcorp’s nAbCyte cell-based neutralizing antibody assay will allow for the accurate detection of preexisting neutralizing antibodies, which could impact patient safety and/or efficacy of the one-time treatment.