Laboratory Corporation of America has announced the receipt of FDA approval for its nAbCyte Anti-AAVRh74var HB-FE Assay, marking a significant milestone in precision medicine. This companion diagnostic tool is designed to ascertain patient eligibility for treatment with Beqvez, Pfizer’s groundbreaking gene therapy for hemophilia B.
The nAbCyte test functions as a cell-based neutralizing antibody assay, detecting preexisting anti-AAVRh74var antibodies that could potentially impact patient safety or treatment efficacy with Beqvez. By providing a clear indication of whether a patient harbors these neutralizing antibodies, the test streamlines the decision-making process for physicians and patients alike. Those who test negative can proceed with consideration for Beqvez treatment.
Hemophilia B, a hereditary bleeding disorder, affects an estimated 6,000 individuals in the United States alone. Moreover, studies suggest that up to 60 percent of the US population may possess preexisting anti-AAV antibodies, highlighting the importance of identifying suitable candidates for gene therapy.
Sonal Bhatia, head of US specialty care medical affairs at Pfizer, emphasized the significance of this development, noting that the approval of the nAbCyte companion diagnostic marks a pioneering step in gene therapy for hemophilia B. It provides invaluable clarity to healthcare professionals and patients weighing the option of Beqvez treatment, thus advancing the therapeutic landscape for this rare condition.
Brian Caveney, Labcorp’s president of early development research laboratories and chief medical and scientific officer, underscored the company’s pride in offering the first FDA-approved cell-based companion diagnostic. This breakthrough not only represents a milestone in companion diagnostics but also promises to transform the lives of patients grappling with rare, genetically inherited conditions like hemophilia B.
