LandschulzNASHsummit19.pdf

NASH Summit 2019 -- Approximately 25-30% of the global adult population have non-alcoholic fatty liver disease (NAFLD), a chronic disease characterized by the accumulation of excess fat in the liver. Between 11-40% of individuals with NAFLD will progress to non-alcoholic steatohepatitis (NASH), in which inflammation, hepatocyte ballooning and fibrosis markedly effect liver function. Active development of novel therapeutic agents for NASH are mirrored by the search for novel, noninvasive tests to further enable identification of patients, including those with active NASH (NAS>4) and fibrosis (F>2). This "Progressing NASH" patient population is at highest risk for poor clinical outcomes, and in greatest need of therapeutic intervention. As such, this population is the frequent focus of NASH clinical trial recruitment. Genfit's Non-invasive Test 4 or "NIS4" has emerged as a promising diagnostic tool for identifying patients with progressing, fibrotic NASH. A licensing agreement between Genfit and Covance/LabCorp, finalized in January 2019, will enable NIS4's availability to the broader clinical trial community. Full implementation of NIS4 within Covance Central Laboratory Services (Covance CLS), described here, requires correlation assessment of each component assay, as well as the test-defining algorithm.