With Medicare reimbursement for its NASHnext® test having taken effect in August, GENFIT finds itself at the center of a rapidly shifting commercial landscape for liver disease diagnostics.
The French biopharmaceutical company is using the AASLD The Liver Meeting 2026 to cement relationships with some of the pharmaceutical industry’s biggest names, including Novo Nordisk, Eli Lilly, and Madrigal, all of which are developing or marketing MASH treatments that depend on reliable patient identification.
Independent validation has added weight to GENFIT’s diagnostic position, with the NIMBLE consortium identifying its NIS™ Technology as the only tool among those evaluated that was specifically designed to diagnose at-risk MASH.
A separate European study, LITMUS, found that the same technology achieved the highest diagnostic accuracy for at-risk MASH across blood-based, imaging, and combined modalities evaluated in that analysis.
Larry Holden, CEO of the Global Liver Institute, framed the stakes bluntly: “We are reaching an important inflection point in MASH: effective treatments are becoming available, making the ability to identify the right patients, particularly those with at-risk MASH, increasingly critical.”
Holden added that “bringing together diagnostic innovators such as GENFIT, leading drug companies including Eli Lilly, Novo Nordisk and Madrigal, clinical experts from hepatology to endocrinology, patients and payers around the same table is exactly the type of dialogue needed to move from scientific progress to real-world implementation.”
GENFIT’s NIS2+®, the next-generation version of the technology, is currently available through Labcorp in the United States as a Laboratory Developed Test, though it has not yet received FDA clearance or CE marking in Europe.
On November 6, an expert panel will draw perspectives from hepatology, endocrinology, and patient advocacy, with professors Vlad Ratziu of Sorbonne University and Kenneth Cusi of the University of Florida joining Wayne Eskridge and Henry Chang from the Fatty Liver Foundation.
Ashley Hamilton Chasick, Global Lead for Diagnostics Partnerships at Novo Nordisk, will contribute an industry perspective on how non-invasive diagnostics can support earlier identification of patients with at-risk MASH.
Alongside the diagnostics push, GENFIT is accelerating its therapeutic program in Acute on-Chronic Liver Failure, with a dedicated scientific event on November 8 set to outline the clinical case for advancing nangibotide into Phase 2.
Nangibotide, a TREM-1 modulator, carries an existing body of clinical evidence at the proposed dose, and GENFIT says available supply and regulatory data support the Phase 2 decision in ACLF.
Professor Jennifer Lai of UC San Francisco will appear as a guest speaker at that event, which will also cover GENFIT’s broader multi-target approach to ACLF’s complex disease pathology.
Three scientific posters on November 6 will present new data on immune dysfunction in acute liver failure, including evidence from ex vivo blood assays showing the anti-inflammatory activity of G1090N, a novel nitazoxanide formulation under consideration for ACLF development.
On November 5, GENFIT management will present its ACLF strategy to the North American Consortium for the Study of End-Stage Liver Disease at a meeting chaired by Professor Jasmohan S. Bajaj of Virginia Commonwealth University.
GENFIT’s partner Ipsen, which acquired an 8% stake in the company in 2021 and markets elafibranor as Iqirvo® following its 2024 regulatory approvals in the US, Europe, and the UK, is also expected to present data at the meeting.
