Genfit and LabCorp’s drug development business Covance have signed a licensing agreement that will expand access to a new diagnostic test for Non-Alcoholic Steatohepatitis (NASH).
NASH is an asymptomatic disease which often advances to life-threatening stages before clinical diagnosis. An invasive procedure, a liver biopsy is currently a standard process to diagnose NASH and stage fibrosis.
Through the agreement, the two companies aim to offer the clinical research community a non-invasive test to detect and monitor patients with NASH and significant fibrosis.
Genfit has already developed a non-invasive multi-parametric blood-based biomarker test called NIS4.
The test utilises a biobank of samples from nearly 700 well-characterised patients to form a novel combination of biomarkers to detect patients with NASH and significant fibrosis.
Under the licensing agreement, the new NASH diagnostic test will be deployed in the clinical research space through Covance’s central laboratories for further validation.
The process is also expected to generate new biological insights into NASH disease pathogenesis.
Genfit chairman and CEO Jean-François Mouney said: “We are very enthusiastic to announce this agreement, which represents a major step in GENFIT’s commercial strategy in NASH.
“The expertise that LabCorp and Covance have in this field will add tremendous value to Genfit’s pioneering work in developing this innovative technology.
“I’m excited to see collaborations like this, which will help move the test toward the goal of being an in vitro diagnostic (IVD) to identify NASH patients who should be considered for therapeutic intervention.”
The companies have not disclosed the financial terms of the agreement.