GENFIT announced the publication of data demonstrating the effectiveness of its non-alcoholic steatohepatitis (NASH) diagnostic technology NIS4(R) 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 panels5, 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 (ALT and FIB-4). 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 (F=2) 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 U.S Food and Drug Administration.

NIS2+?, the newly published and optimized version of NIS4®, is currently in the process of being independently evaluated through the NIMBLE consortium.