Genfit publishes NIS4 NASH diagnostic technology data

Genfit announced the publication of data demonstrating the effectiveness of its non-alcoholic steatohepatitis, or NASH, diagnostic technology NIS4 by the FNIH’s NIMBLE project in the scientific journal, Nature Medicine. NIMBLE, part of the FNIH Biomarkers Consortium, is a public-private partnership that brings together U.S. government agencies, academic researchers and industry partners to study the diagnostic performance of non-invasive biomarkers to assess liver disease. The recent study evaluated five blood-based panels, which included NIS4, NIS2+’s predecessor. The study aims to confirm the diagnostic performances of existing biomarker panels and determine their advantage over commonly used laboratory tests. Such studies conducted provide necessary data for the regulatory approval of biomarkers for the diagnosis of at-risk NASH and is a crucial step in moving the field closer to having qualified Non-Invasive Tests, such as NIS4 or now NIS2+, that can be used for widespread clinical use. The findings, published in the scientific journal Nature Medicine, concluded that NIS4 achieved an AUROC6 of 0.815 for its intended use of diagnosing at-risk NASH, demonstrating significant superiority over common clinical-laboratory tools. It also confirmed that NIS4 was the only panel efficient for the diagnosis of the composite phenotype of at-risk NASH. Regarding the detection of NASH and significant fibrosis independently, NIS4’s performance was superior to the other biomarker panels tested, achieving AUROC values of 0.832 and 0.874, respectively. These findings represent an important milestone in NIS4 technology’s path to regulatory approval by the FDA. NIS2+, the newly published and optimized version of NIS4, is currently in the process of being independently evaluated through the NIMBLE consortium.