Labcorp OKd on 1st Diagnostic for Pfizer Hemophilia B Gene Therapy

  Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's 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 (rAAV)-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 (nAbs), which could impact patient safety and/or efficacy of the one-time treatment.

https://www.prnewswire.com/news-releases/labcorp-receives-fda-approval-for-first-companion-diagnostic-for-use-with-pfizers-newly-approved-gene-therapy-to-treat-patients-with-hemophilia-b-302129932.html