FX.co ★ Labcorp: FDA Approves NAbCyte Companion Diagnostic - Quick Facts

Labcorp has announced that the FDA has granted approval for its nAbCyte Anti-AAVRh74var HB-FE Assay. This new protocol is created to function as a companion diagnostic in order to assess a patient's eligibility for BEQVEZ therapy. BEQVEZ is a recently FDA-approved gene therapy designed by Pfizer to treat hemophilia B. The results of the nAbCyte test will be recorded simply as negative or positive. A negative result means a patient who has moderate to severe hemophilia B can be considered for the BEQVEZ treatment.

Pfizer's Head of U.S. Specialty Care Medical Affairs, Sonal Bhatia, stated, "This companion diagnostic is a crucial instrument for determining patients who may be suitable for gene therapy, as the treatment strategy progresses with the introduction of gene therapies like BEQVEZ."

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