Lille, France; Cambridge, Massachusetts, United States; and Zurich, Switzerland, July 2, 2026
GENFIT announced that U.S. Medicare has approved coverage and future reimbursement for NASHnext®, Labcorp’s non-invasive blood-based diagnostic test powered by GENFIT’s proprietary NIS4® technology for identifying patients with at-risk metabolic dysfunction-associated steatohepatitis (MASH). The reimbursement, scheduled to become effective on August 10, 2026, represents a major commercial and clinical milestone for the biotechnology company as the diagnostic test becomes eligible for reimbursement under the Medicare Clinical Laboratory Fee Schedule at approximately $252 per test. Developed and commercialized by Labcorp under a licensing agreement with GENFIT, NASHnext is designed to identify patients with active disease and clinically significant fibrosis, including Stage F2 fibrosis, allowing physicians to intervene earlier before progression to advanced liver damage. The milestone is also expected to support broader adoption by private insurers while creating an additional revenue stream for GENFIT through its licensing partnership.
NASHnext Addresses Growing Need for Early MASH Detection
The NASHnext blood test combines multiple biomarkers through GENFIT’s proprietary NIS4 technology to evaluate both disease activity and fibrotic burden using a simple blood sample, eliminating the need for invasive liver biopsies in many patients. The diagnostic is particularly intended for individuals at elevated risk of MASH, including patients with prediabetes, type 2 diabetes, obesity, dyslipidemia, and other metabolic disorders. According to GENFIT, the United States is expected to see approximately 260 million adults with metabolic disease risk factors, nearly 170 million diagnosed with metabolic disorders, and close to 90 million individuals with elevated liver enzymes or liver steatosis over the coming years. These figures highlight the substantial unmet need for scalable, non-invasive diagnostic technologies capable of identifying patients before irreversible liver damage develops. By improving early detection, NASHnext may help clinicians make more timely treatment decisions as new therapeutic options become increasingly available.
Medicare Reimbursement Supports Broader Clinical Adoption
Healthcare experts noted that securing Medicare coverage represents an important step toward integrating non-invasive blood-based diagnostics into routine clinical practice for patients with MASH. Physicians emphasized that many individuals remain undiagnosed until liver disease has significantly progressed because early-stage MASH often produces few symptoms. The availability of a reimbursed, accessible diagnostic test is expected to improve patient identification while supporting more efficient referral pathways for treatment. Clinical experts also highlighted that reimbursement removes a significant barrier to adoption, allowing healthcare providers to incorporate testing into everyday practice and enabling patients to access earlier evaluation through a structured clinical framework. As additional therapies for MASH continue advancing toward commercialization, identifying eligible patients earlier will become increasingly important for maximizing treatment benefit and improving long-term liver health outcomes.
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GENFIT Strengthens Its Position in the Expanding MASH Market
The Medicare reimbursement milestone significantly strengthens GENFIT’s commercial strategy as the company expands beyond therapeutic development into precision liver disease diagnostics. Through its licensing agreement with Labcorp, GENFIT expects NASHnext to become an important second source of recurring revenue while supporting widespread clinical adoption across the United States. The announcement comes at a pivotal time for the MASH market, where the first approved therapy has already demonstrated strong commercial performance and additional treatment candidates from major pharmaceutical companies continue to advance through late-stage development. By combining validated NIS4 biomarker technology, scalable laboratory testing, and now Medicare reimbursement, GENFIT is well positioned to play a central role in the evolving management of metabolic liver disease. The company expects to provide additional commercial guidance regarding the opportunity during its upcoming business updates later this year.
Source: GENFIT, press release
