LabCorp® (NYSE: LH), a leading global life sciences company, and GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, have announced the signing of a licensing agreement between GENFIT and Covance, LabCorp’s drug development business. The agreement will expand access to an innovative non-alcoholic steatohepatitis (NASH) liver diagnostic test for the clinical research market.
NASH is a silent, asymptomatic disease that often progresses to more serious and life-threatening stages before a clinical diagnosis is made. Liver biopsy, a highly invasive procedure, is currently the clinical standard to formally diagnose NASH and stage fibrosis. Furthermore, there are currently no extensively validated non-invasive diagnostic tests in NASH to address evolving disease and therapeutic implications, providing clinical and market opportunities for new product innovations.
To address this pressing need, GENFIT has developed a novel, non-invasive test created specifically for NASH. This multi-parametric blood-based biomarker test, named NIS4, leveraged a rich biobank of samples from roughly 700 well-characterized patients to establish a novel combination of biomarkers to identify and monitor patients with NASH and significant fibrosis. The primary focus of the licensing agreement will be to deploy NIS4 in the clinical research space through Covance’s central laboratories to further validate the test’s use for better identification and characterization of patients, and to generate new biological insights on NASH disease pathogenesis.