Announcement • Jun 09

Genfit Launches Nashnext Test Powered by Nis4 Technology Via Labcorp Ondemand for Identification of At-Risk Mash

GENFIT 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. 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. 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. 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. 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. 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.

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