LabCorp, Genfit Partner to Commercialize Liver Disease Diagnostic Test

NEW YORK – Laboratory Corporation of America announced Monday an exclusive licensing agreement with Genfit to commercialize Genfit's NIS4 technology for patients with non-alcoholic steatohepatitis (NASH). 

Under the five-year agreement, LabCorp will develop and commercialize a blood-based molecular diagnostic test driven by NIS4 technology to identify patients with at-risk NASH. Genfit's NIS4 is a multibiomarker-based algorithm developed to identify the presence of NASH based on a non-alcoholic fatty liver disease activity score greater than or equal to four and significant to advanced fibrosis. The single test score integrates the miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c biomarkers. 

LabCorp will offer the test to specialty and primary care physicians across the US and Canada by early 2021, the firm said. The two companies began collaborating in 2019, when LabCorp started offering the NIS4 technology to biopharmaceutical customers for use in clinical studies. 

Patients with at-risk NASH "face a greater likelihood of progression to severe complications including liver cancer, cirrhosis, and the need for liver transplant, if left untreated," LabCorp said in a statement. 

Financial and other terms of the agreement were not disclosed.