Validation and implementation of NIS2+® test for identification of patients with at-risk MASH

Paris MASH 2025 -- Newly developed non-invasive tests enable the identification of metabolic dysfunction-associated steatohepatitis (MASH) patients, including those with significant or advanced liver fibrosis (F≥2). NIS4®, a multivariate blood-based assay developed by GENFIT, has recently been optimized to allow the generation of the NIS2+® algorithm. NIS2+® is a serum-based test combining two biomarkers (CHI3L1 [also known as YKL-40] and miR-34a-5p) plus a correction for gender, intended for patients with metabolic risk factors and suspicion of liver disease. Retrospective studies showed that NIS2+® offers improved robustness as compared to NIS4® for the detection of patients with at-risk MASH. Recently, a prospective study confirmed NIS2+® as the best test for at-risk MASH patients’ detection. Using NIS2+® also improved patient selection during screening in clinical trials by reducing liver biopsy failure rates. NIS2+® optimizes the NIS4® algorithm with robust performance against T2D and minimizing the required sample volume. We performed a full analytical validation and implementation of NIS2+® at Labcorp.