Enabling Gene Therapy Access: Labcorp's First Cell-Based Companion Diagnostic (CDx)

The rise of innovative gene therapies has led to the need for specialized cell-based companion diagnostic (CDx) assays, which present various technical and operational challenges. Labcorp collaborated with a sponsor to develop the nAbCyte™ CDx assay, a critical tool for determining patient eligibility for the novel gene therapy program, BEQVEZ™ (fidanacogene elaparvovec). The nAbCyte assay, an FDA-approved in vitro CDx device, detects neutralizing antibodies against the AAVRh74var capsid in serum specimens from patients diagnosed with hemophilia B.

This case study highlights how Labcorp successfully partnered with the client and regulatory agencies to overcome developmental challenges by employing a customized approach that leveraged scientific expertise, strategic collaboration, and effective governance.