The emergence of novel gene therapies has necessitated the development of cell-based CDx assays, posing multiple technical and operational challenges. Labcorp worked with a sponsor to develop the nAbCyte™ CDx assay to determine patient eligibility for a novel gene therapy program BEQVEZ™ (fidanacogene elaparvovec). nAbCyte is an FDA-approved in vitro CDx device that detects neutralizing antibodies to the AAVRh74var capsid in serum specimens from patients previously diagnosed with hemophilia B. This case study illustrates how Labcorp worked with the client and regulatory agencies to overcome development hurdles with a customized approach combining scientific expertise, collaboration, strategic engagement and governance.

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