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Labcorp Receives FDA Approval for CDx for Pfizer Hemophilia B Gene Therapy

NEW YORK – Laboratory Corporation of America said Monday that it has received US Food and Drug Administration for its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to determine patient eligibility for treatment with Beqvez (fidanacogene elaparvovec), Pfizer's recently FDA-approved hemophilia B gene therapy.

The nAbCyte test is a cell-based neutralizing antibody assay that detects preexisting anti-AAVRh74var antibodies that could impact patient safety or the efficacy of treatment with Beqvez.

The test will report that a patient is either positive or negative for these preexisting neutralizing antibodies. Patients who test negative can be considered for treatment with Beqvez.

According to Labcorp, roughly 6,000 people in the US have hemophilia B, an inherited bleeding disorder that prevents normal blood clotting. Estimates indicate that up to 60 percent of the US population has preexisting anti-AAV antibodies.

"The approval of the nAbCyte companion diagnostic represents a first for a gene therapy that treats eligible patients with hemophilia B, helping to bring clarity to physicians and patients who are considering Beqvez as a treatment option," said Sonal Bhatia, head of US specialty care medical affairs at Pfizer. "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."

"Labcorp is proud to offer the first cell-based, companion diagnostic to receive FDA approval, which represents a pioneering breakthrough in the field of companion diagnostics and will help transform the therapeutic landscape and the lives of patients living with rare, genetically inherited conditions," Brian Caveney, Labcorp president of early development research laboratories and chief medical and scientific officer, added in the firm’s statement.