Diagnostics

We have advanced a non-invasive diagnostic program based on the identification of specific biomarkers that are expressed at different levels in patients with Non-Alcoholic Steatohepatitis (NASH), now called MASH¹ (Metabolic dysfunction-Associated Steatohepatitis). This discovery kicked off a multi-year effort that has resulted in the development of a blood-based molecular technology for the identification of patients with NASH/MASH (NAS≥4) and significant fibrosis (F≥2).

NIS4^®

Our first biomarker technology, NIS4^®, integrated the outputs of four NASH/MASH-associated biomarkers (alpha-2-macroglobulin, YKL-40, hemoglobin A1c, and miR-34a-5p) through an algorithm to produce a single score that can be utilized to rule in and rule out at-risk NASH/MASH, while minimizing the number of indeterminate test results. Its utility was recognized in a Stage 1 study undertaken by the NIMBLE (Non-Invasive Biomarkers of Metabolic Liver Disease) initiative of the FNIH (Foundation for the National Institutes of Health) Biomarkers Consortium as demonstrating a unique performance in identifying patients with “at-risk” NASH/MASH. In August 2020, pivotal data describing the derivation and validation of NIS4^® technology was accepted for publication by The Lancet Gastroenterology & Hepatology.² In 2021, we entered into an agreement with Labcorp to commercialize NASHnext^®, powered by GENFIT’s proprietary diagnostic technology NIS4^® in identifying at-risk NASH/MASH.

NIS2+^®

In October 2022, we optimized NIS4^® and announced compelling results on the clinical performance of NIS2+^® which we presented at AASLD (American Association for the Study of Liver Diseases). NIS2+^® has demonstrated the robust and improved clinical performance of NIS2+^® allowing an efficient identification of at-risk NASH/MASH, irrespective of patient characteristics such as age, sex and type 2 diabetes. In 2023 the performance of NIS2+^® was published in the Journal of Hepatology³ and in Hepatology Communications.⁴

We continue to explore the possibility of obtaining regulatory approval and CE Certificates of Conformity, with a development and commercial partner, to release an IVD test powered by NIS2+^® technology on the US and European markets.

The TS-01 program consists of developing a diagnostic device based on a “transmembrane pH-gradient polymersome” technology. It is in a prototype stage of development for point-of-care, including at-home measurement of ammonia in blood.

The goal of this project is to build a prototype device that will be fast, selective, and sensitive over a wide range of ammonia concentrations, covering physiological and pathological levels.