GENFIT SA (GNFT:NADSAQ; GNFT:EURO), which is focused on metabolic and liver diseases, and global life sciences company LabCorp® (LH:NYSE), today announced that "they have agreed to a five-year exclusive licensing agreement for GENFIT's NIS4™ technology to help identify patients with at-risk non-alcoholic steatohepatitis (NASH)."
Under the terms of the agreement, LabCorp is tasked to develop and commercialize a blood-based molecular diagnostic test powered by NIS4 technology. The test is expected to be available from LabCorp by early 2021 and will be marketed throughout the U.S. and Canada to healthcare providers with the goal of identifying the approximately 10 million individuals at risk of progressing to late stage complications due to NASH among the tens of millions of people with metabolic risk factors and suspected disease.
The report noted that NASH, due to its asymptomatic nature and the limitations of existing diagnostic approaches, remains a highly under-diagnosed disease. The current clinical standard of care to diagnose NASH and to evaluate the stage of the disease's progression is to perform a highly invasive liver biopsy.
LabCorp Diagnostics' Chief Scientific Officer Marcia Eisenberg, Ph.D., commented, "LabCorp is committed to developing and distributing novel diagnostics to support the diagnosis of patients with NASH, which is one of the fastest growing serious medical conditions in the U.S. GENFIT's NIS4™ is a non-invasive technology specifically designed to identify patients with both NASH and significant to advanced fibrosis, and is an important advance in the ability to identify patients with NASH. We have gained valuable experience with this test since we began performing it in 2019 for clinical studies with biopharmaceutical clients, which will provide insights as we develop and prepare to make it available for use in patient care."
GENFIT's CEO Pascal Prigent remarked, "This partnership supports GENFIT's pioneering research efforts in the field of NASH diagnostics that were recently recognized by experts in our most recent Lancet publication. The commercialization of NIS4™ technology by LabCorp is a defining opportunity whereby millions of NASH patients can become aware of, and then begin to take control of their disease."
GENFIT's Head of Global Diagnostics Suneil Hosmane, Ph.D., added, "We are pleased to expand our collaboration with LabCorp and are very enthusiastic about the potential impact of this agreement. We strongly believe that this test will help healthcare providers identify the approximately 10 million patients with at-risk NASH and higher risk of progression among the tens of millions with metabolic risk factors, such as type 2 diabetes and obesity, and suspected disease."
The report advised that that the exact financial details for the agreement between GENFIT and LabCorp have not been disclosed.
The companies explained that "NIS4™ is GENFIT's non-invasive, blood-based diagnostic technology, which was developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH." GENFIT noted that in January 2019 it executed a licensing agreement to make NIS4 technology available for use in clinical research with LabCorp's subsidiary Covance.
GENFIT is a late-stage biopharmaceutical company based in Lille, France, with additional facilities located in Paris and Cambridge, Mass. The firm employs around 200 people and focuses its efforts in the area of metabolic and liver diseases.
Laboratory Corporation of America Holdings (LabCorp) is a global life sciences company headquartered in Burlington, N.C. The firm provides comprehensive clinical testing, laboratory and end-to-end drug development services. LabCorp, which was reported to be a global leader in NASH clinical trials, has been engaged in developing drugs and diagnostics for greater than 50 years. The company posted greater than $11.5 billion in revenue in 2019.
GENFIT started off the day with a market capitalization of around $162 million with approximately 38.86 million shares outstanding. GNFT shares opened nearly 39% higher today at $5.81 (+$1.62, +38.66%) over Friday's $4.19 closing price. The stock has traded today between $5.32 and $5.94 per share and is currently trading at $5.44 (+$1.26, +29.95%).
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