Healthcare
GENFIT Announces U.S. Medicare Coverage and Future Reimbursement for NASHnext®, a Non-Invasive Diagnostic Technology to Identify Patients with At-Risk MASH
Coverage and future reimbursement (effective August 10, 2026) secured for NASHnext®, Labcorp’s non-invasive blood-based diagnostic test powered by GENFIT’s proprietary NIS4® technologyFocuses on patients at highest risk, including those with prediabetes, type 2 diabetes, obesity and dyslipidemia A technology positioned for scale at a key inflection point in the U.S. MASH market, with the first therapy already achieving near-blockbuster status in its first year and additional agents from leading
About this update from Genfit Sa
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), July 2, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the coverage and future reimbursement by U.S. Medicare for NASHnext®, a non-invasive blood test available through Labcorp, a global leader of innovative and comprehensive laboratory services. This will support large-scale adoption and additional revenue for GENFIT. NASHnext® is a diagnostic test developed and commercialized by Labcorp as a laboratory developed test (LDT) under license from GENFIT. Built on GENFIT's technology, the test uniquely captures both disease activity and fibrotic burden, including F2 (stage 2 fibrosis), delivering clinically meaningful insights to support earlier identification of at-risk patients and allow for more informed clinical decision-making across care settings. NASHnext® will be reimbursed by Medicare under the Clinical Laboratory Fee Schedule at approximately $252 per test.1 Reimbursement to Medicare patients that meet coverage criteria2 will become effective beginning August 10, 2026. This major milestone supports broader adoption and future coverage by private insurers. In the U.S., projections point to a substantial and expanding population with a high metabolic burden over the coming years, with approximately 260 million adults expected to present risk factors for metabolic disease, around 170 million expected to be diagnosed with metabolic disease (prediabetes, type 2 diabetes, obesity, hypertension, hyperlipidemia, etc.), and nearly 90 million expected to exhibit elevated liver enzymes and/or steatosis.3 Together, these figures underscore the scale of the diagnostic gap and the need for earlier, non-invasive identification of patients already within the MASH spectrum and at risk of progression.