- Labcorp OnDemand enables convenient testing with the NASHnext® test, within a physician-directed care pathway to support identification of patients with at-risk MASH
- This model expands access and supports adoption of NASHnext®, enabling testing across a wider patient population
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 8, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that access to Labcorp’s NASHnext®, a diagnostic test to identify at-risk MASH (Metabolic dysfunction-Associated SteatoHepatitis), powered by GENFIT’s proprietary non-invasive diagnostic technology NIS4®, is now available through Labcorp OnDemand. Labcorp’s platform allows patients expanded access to certain diagnostic tests online, which a physician can approve and review without requiring an in-person doctor's visit.
Addressing a major diagnostic gap in routine care
Against the backdrop of widespread adoption of new therapeutic options in MASH, current diagnostic tools fall short: commonly used blood-based scores rely on indirect parameters, while liver imaging remains costly, resource-intensive, and ill-suited to large-scale early detection. Unlike other existing diagnostic options, GENFIT’s non-invasive technology was specifically designed to identify patients with at-risk MASH and is able to power a test that can capture both disease activity and fibrotic burden even if still at F2 (stage 2 fibrosis), thus providing helpful information to support clinical evaluation, diagnosis, and treatment decisions. By enabling earlier and more accurate identification of at-risk patients, this approach helps address key diagnostic gaps across primary care, endocrinology, and broader clinical settings.
What the Labcorp OnDemand availability enables
Labcorp’s NASHnext® is now available through Labcorp OnDemand, a digital interface for patients that provides them with an additional access channel to healthcare professionals within the routine care framework, with all testing requests reviewed by a healthcare professional. It is intended to broaden access to testing in the United States, in anticipation of a reimbursement decision by Medicare/Medicaid that would enable access across relevant patient populations. NASHnext® testing could be useful to a U.S. patient population in the high tens of millions of individuals, reflecting the need to screen broadly to identify patients with at-risk MASH. This estimate is informed by the high and growing prevalence of metabolic risk factors in the U.S., including type 2 diabetes, obesity, or dyslipidemia, with a clear majority of adults presenting at least one such risk factor. Within this large population, a significant proportion already presents with elevated liver markers, and a subset may ultimately be eligible for treatment, with potential additional use in monitoring.
Pejvack Motlagh, Chief Medical Officer at GENFIT, commented: “In a highly prevalent condition like MASH, enabling simple, scalable access to clinically validated testing is essential to identify at-risk patients earlier in routine care, including in primary care and endocrinology settings. Expanding access must go hand in hand with appropriate clinical oversight to ensure patients are not only tested, but also properly managed based on their results.”
Test methodology, patient journey and clinical interpretation of results
NASHnext® evaluates multiple blood-based markers associated with liver fat, inflammation, and liver fibrosis. Unlike routine liver enzyme tests alone, this approach looks at how several markers relate to each other. Results are intended to support clinical follow-up and monitoring decisions when interpreted by a healthcare provider and are only one part of a broader liver health evaluation. In practice, via the OnDemand platform, patients can order the test online, go to a patient service center for the blood draw, and see their test results rapidly on MyLabcorp app. Commercial landing page on NASHnext®: www.ondemand.labcorp.com/lab-tests/nashnext-advanced-liver-risk-test.
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ABOUT NASHNEXT®, NIS4® AND NIS2+®
With a high and growing prevalence of metabolic risk factors in the U.S., early detection of at-risk MASH could benefit a U.S. patient population in the high tens of millions of individuals, highlighting a significant unmet medical need. Liver biopsy currently remains the clinical standard for diagnosing at-risk MASH, but its use is highly constrained by its invasive and costly nature and difficult scalability. Labcorp’s NASHnext® is a non-invasive diagnostic test to easily identify patients with at-risk MASH (Metabolic dysfunction-Associated SteatoHepatitis). It is powered by GENFIT’s proprietary non-invasive diagnostic technology NIS4®. NIS4® and next-generation technology NIS2+® have been widely recognized over the past few years as showing a unique performance in identifying patients with at-risk MASH. This recognition is reflected through a growing body of scientific evidence (including publications in The Lancet and Nature Medicine), inclusion in joint guidelines from several international scientific societies (EASL-EASD-EASO), strong visibility within major consortia in the U.S. and Europe (NIMBLE and LITMUS), and its use in most large clinical trials conducted by key industry players in MASH. Today NASHnext® is available through Labcorp OnDemand, a digital interface where patients can order the test online. GENFIT is actively seeking to advance partnerships with pharmaceutical companies to support wider deployment of non-invasive testing for at-risk MASH and accelerate adoption in line with the expansion of MASH therapies. GENFIT is also exploring the development of an IVD-labeled (In Vitro Diagnostic) version of its non-invasive diagnostic technology, either independently or in collaboration with a diagnostic-focused partner, with the selected approach expected to reflect the most appropriate route to maximize long-term value for GENFIT.
ABOUT GENFIT
GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for second-line treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements regarding the expansion of the population eligible to access Labcorp’s NASHnext® test powered by NIS4®, GENFIT’s proprietary non-invasive diagnostic technology, its adoption as a diagnostic test to identify patients with “at-risk” MASH, the size of this population, and potential reimbursement for this test by Medicare and Medicaid. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2025 Universal Registration Document filed on April 3, 2026 (no. 26-0221) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in reports filed with the AMF or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
CONTACTS
GENFIT | Investors
Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 |
jean-christophe.marcoux@genfit.com
GENFIT | Media
Bruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr
Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com
1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®
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