GENFIT Highlights Long-Term Opportunity for MASH Diagnostics

GENFIT, a biopharmaceutical company based in France, has highlighted the significant long-term commercial opportunity associated with its NIS4® and next-generation NIS2+® diagnostic technologies. These non-invasive blood-based tests are designed to identify patients at risk for Metabolic dysfunction-Associated SteatoHepatitis (MASH), a condition that affects nearly 90 million individuals in the United States who are already receiving medical attention for related risk factors.

According to IQVIA, a global leader in healthcare information and analytics, the potential peak sales of products based on NISTM Technology, which underpins GENFIT’s diagnostic tools, could exceed $1.5 billion by 2033. This projection underscores the substantial market potential for GENFIT, especially given the expanding therapeutic landscape for MASH.

The foundations for broader adoption of GENFIT’s NISTM Technology are expected to strengthen in the coming months. This is supported by factors such as expanding reimbursement, increased incorporation into clinical guidelines, and growing disease awareness. Pharmaceutical companies commercializing MASH therapies are also expected to invest heavily in physician education, patient identification, and disease monitoring initiatives, further driving the demand for reliable diagnostic tools.

Prof. Vlad Ratziu, a renowned hepatologist and researcher, emphasized the need for reliable, simple, and scalable serum-based tools to identify patients with active fibrotic MASLD. "We cannot treat patients that we cannot correctly identify," he stated. "We need tools that can support disease monitoring and clinical decision-making over time."

The unmet need in MASH diagnostics is significant. By 2033, 86 million Americans closely managed in the care system for elevated enzymes or steatosis may benefit from non-invasive, blood-based testing approaches. These tools will help identify patients with at-risk MASH and support disease monitoring and long-term management.

In the United States, IQVIA estimates that the annual testing volume could reach over 7 million tests by 2033, potentially generating peak sales of over $1.5 billion. GENFIT plans to commercialize its technology through a staged strategy, initially focusing on Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs). The company expects broader reimbursement coverage across geographies, including potential private payer coverage, to support accelerated adoption.

Beyond the United States, GENFIT anticipates that its IVD strategy will play a key role in international markets. The anticipated expansion of the MASH therapeutic market and the broader accessibility enabled by IVD products could represent a meaningful additional revenue opportunity.

Reimbursement and market access are key drivers for GENFIT’s technology. In August 2026, Medicare reimbursement for Labcorp's NASHnext® test, which is based on GENFIT's NISTM Technology, became effective under the Clinical Laboratory Fee Schedule. This development is expected to facilitate wider adoption of the technology.

Scientific recognition and clinical guidelines inclusion have also contributed to the growing acceptance of NISTM Technology. The LITMUS and NIMBLE consortia highlighted the unique ability of NISTM Technology to assess both disease activity and fibrosis, a key differentiator for identifying patients with at-risk MASH and supporting clinical decision-making.

Pharmaceutical companies commercializing MASH therapies are expected to invest heavily in physician education, disease awareness, and patient identification initiatives. NISTM Technology is already incorporated into or evaluated in connection with more than 20 large-scale clinical studies conducted by leading companies developing therapies for MASH, including Novo Nordisk, Eli Lilly, AstraZeneca, Akero, and others.

Recognizing the growing burden of MASLD/MASH as a public health challenge, GENFIT and the Global Liver Institute (GLI) are establishing a non-partisan coalition. The coalition aims to advance awareness, earlier patient identification, and improved care pathways to ensure that advances in treatment translate into meaningful benefits for the millions of people affected by MASLD and MASH.

GENFIT continues to generate scientific evidence supporting NISTM technology to allow its broader incorporation in routine practice. The company remains committed to improving the lives of patients with rare and life-threatening liver diseases, with a focus on Acute on-chronic Liver Failure (ACLF), associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE), and other serious diseases like cholangiocarcinoma (CCA), urea cycle disorders (UCD), and organic acidemia (OA).

The development of reliable, non-invasive diagnostic tools for MASH is expected to transform patient management and disease monitoring. As the market for MASH diagnostics expands, GENFIT is well-positioned to capitalize on the significant commercial opportunities presented by its NIS4® and NIS2+® technologies.