NEW YORK (360Dx) – Laboratory Corporation of America announced today that its Covance drug development business has signed a licensing agreement with Genfit to use a non-alcoholic steatohepatitis liver diagnostic (NASH) assay in the clinical research market.
Lille, France-based Genfit's NASH assay, called NIS4, is a blood-based biomarker test that uses alpha-2 macroglobulin, HbA1c, YKL-40, and the microRNA miR-34a 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. Terms of the agreement were not disclosed.
Genfit Chief Operating Officer Dean Hum previously said that the company was trying to time the development and approval of the test so that it would become available at the same time as the company's NASH drug, elafibranor. At the time, the company was aiming for regulatory approval for clinical use of the drug and the diagnostic around 2020 or 2021 in both Europe and the US. Elafibranor is currently being evaluated in Phase III studies, according to the company.
The clinical standard for formally diagnosing NASH is liver biopsy, and there are currently no extensively validated noninvasive diagnostic tests for NASH, according to a statement from the companies.
Genfit Chairman and CEO Jean-Francois Mouney called the licensing agreement "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."
LabCorp and Covance will leverage clinical trial biomarker and diagnostic development experience to validate the NIS4 algorithm, according to Marcia Eisenberg, chief scientific officer of LabCorp Diagnostics.
"We are well-positioned to expand access to NIS4 to the global clinical research community through this agreement," she said.