GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and severe liver diseases, today announced
the publication of data demonstrating the effectiveness of its non-alcoholic steatohepatitis (NASH)1
diagnostic technology NIS4® by the FNIH’s 2 NIMBLE 3 project in the scientific journal, Nature
Medicine4.
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
AUROC 6 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
GENFIT | 885 Avenue Eug̬ne Avin̩e, 59120 Loos РFRANCE | +333 2016 4000 | www.genfit.com 2
PRESS RELEASE
NIS4® , is currently in the process of being independently evaluated through the NIMBLE
consortium.
Arun J Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and
Metabolic Health at Virginia Commonwealth University and Chair of the NIMBLE
Consortium, commented: “Such findings will bring us a step closer towards a fully approved
biomarker panel which can be made available for widespread clinical use and potentially alleviate the
major barrier to care and drug development access. NIS4®’s utility as an effective technology to
diagnose at-risk NASH is clearly demonstrated in these findings and we look forward to evaluating
NIS4®’s more advanced version, NIS2+™, in the near future.”
