Genfit, Lille, France, and Cambridge, Mass, and LabCorp, Burlington, NC, have agreed to a 5-year exclusive licensing agreement for Genfit’s NIS4 technology to help identify patients with at-risk nonalcoholic steatohepatitis (NASH). As part of the agreement, LabCorp will develop and commercialize a blood-based molecular diagnostic test powered by NIS4 technology throughout the United States and Canada.

NASH remains a highly underdiagnosed disease due to its asymptomatic nature and the limitations of existing diagnostic approaches. Liver biopsy, a highly invasive procedure, is the current clinical standard to formally diagnose NASH and to determine the stage of fibrosis. NIS4 technology is a novel, multi-biomarker-based algorithm specifically developed to identify at-risk NASH, defined as the presence of NASH based on a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) less than or equal to 4 and significant to advanced fibrosis (F≥2).1

Patients with at-risk NASH have an advanced form of the disease and face a greater likelihood of progression to severe complications including liver cancer, cirrhosis, and the need for liver transplant, if left untreated. A single test score generated from the integration of four independent biomarkers—miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c—can be used by a healthcare provider to help inform the best course of intervention.  

This agreement with LabCorp will provide broad clinical availability of the test to specialty and primary care physicians across the United States and Canada. LabCorp will leverage its deep experience in commercializing innovative diagnostics to educate providers on NASH and the importance of noninvasive testing. 

“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 United States, says Marcia Eisenberg, PhD, chief scientific officer of LabCorp Diagnostics, “Genfit’s NIS4 is a noninvasive 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.”

The test is expected to be available from LabCorp by early 2021.

For more information, visit LabCorp and Genfit. 

Reference

1. Harrison SA, Ratziu V, Boursier J, et al. A blood-based biomarker panel (NIS4) for non-invasive diagnosis of non-alcoholic steatohepatitis and liver fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. Epub. August 4, 2020. doi:10.1016/S2468-1253(20)30252-1.