Covance, the drug development business of LabCorp, Burlington, NC, has joined in a licensing agreement with Genfit, Lille, France, and Cambridge, Mass, a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases. The agreement will provide Covance with expanded access to an innovative nonalcoholic 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 for formally diagnosing NASH and staging fibrosis. There are currently no extensively validated noninvasive NASH diagnostics to assess the evolving disease and its therapeutic implications, leaving clinical and market opportunities for new product innovations.
To address this pressing need, Genfit has developed a novel, noninvasive test created specifically for NASH. The multiparametric blood-based biomarker test, named NIS4, was developed using a biobank of samples from roughly 700 well-characterized patients to establish a novel combination of biomarkers for identifying and monitoring patients with NASH and significant fibrosis.
The primary focus of the licensing agreement will be to deploy NIS4 through Covance’s central research laboratories in order to further validate the test’s use for better identification and characterization of patients, and to generate new biological insights about NASH disease pathogenesis.
Jean-François Mouney, Genfit.
“We are very enthusiastic to announce this agreement, which represents a major step in Genfit’s commercial strategy in NASH,” says Jean-François Mouney, chairman and CEO of Genfit. “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 to identify NASH patients who should be considered for therapeutic intervention.”
“LabCorp and Covance will be able to leverage our experience in clinical trial biomarkers and diagnostics development to validate the NIS4 algorithm,” says Marcia Eisenberg, PhD, chief scientific officer at LabCorp Diagnostics. “We are well positioned to expand access to NIS4 to the global clinical research community through this agreement. Forward-thinking collaborations like this one enable early and efficient validation of diagnostics that have the potential to significantly impact patients with serious, life-changing unmet medical needs, including NASH.”
Genfit is a pioneer in NASH therapeutics and diagnostics development. Both LabCorp Diagnostics and Covance have been involved in the development of drugs and diagnostics for more than 20 years, and Covance is a recognized global leader in NASH clinical trials.
For further information, visit LabCorp, Covance, and Genfit.
