Labcorp: FDA Approves NAbCyte Companion Diagnostic - Quick Facts

(RTTNews) - Labcorp (LH) announced the FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to determine patient eligibility for treatment with BEQVEZ, Pfizer's recently FDA-approved hemophilia B gene therapy. The results from the nAbCyte test will be reported qualitatively as negative or positive. A negative test result indicates that an individual with moderate to severe hemophilia B can be considered for BEQVEZ therapy.

Sonal Bhatia, Head of U.S. Specialty Care Medical Affairs, Pfizer, said: "We believe this companion diagnostic is an important tool for evaluating patients who may be suitable for gene therapy as the treatment paradigm advances with the introduction of gene therapies like BEQVEZ."

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