LabCorp, a leading global life sciences company, and GENFIT , a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver 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.
“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,” said Jean-François Mouney, chairman & CEO of GENFIT.
“LabCorp and Covance will be able to leverage our experience in clinical trial biomarkers and diagnostics development to validate the NIS4 algorithm,” said Marcia Eisenberg, Ph.D., chief scientific officer of 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.
LabCorp , an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported net revenues of more than $10 billion for 2017. To learn more about LabCorp, visit www.LabCorp.com , and to learn more about Covance Drug Development, visit www.Covance.com