Genfit: Its MASH Screening Test Now Available on Labcorp OnDemand
Genfit announced on Monday the availability of its NASHnext diagnostic test on the digital platform Labcorp OnDemand, allowing patients to access screening for metabolic steatohepatitis (MASH) without a physical consultation. This launch aims to address a major gap in the early diagnosis of MASH in routine practice.
A Test Designed to Identify Patients at Risk of MASH
NASHnext, powered by Genfit's proprietary diagnostic technology NIS4, assesses multiple blood markers associated with hepatic steatosis, inflammation, and liver fibrosis. Unlike standard hepatic enzyme tests alone, this approach examines how several markers relate to each other. The test is specifically designed to identify patients with MASH at risk, including at stage F2 (stage 2 fibrosis), providing information intended to support clinical evaluation and treatment decisions. The results, interpreted by a healthcare professional, are just one component of a broader assessment of liver health.
Expanded Access via a Supervised Digital Pathway
On the Labcorp OnDemand platform, patients can order the test online, go to a collection center for blood draw, and consult their results quickly via the MyLabcorp app. All test requests are reviewed and approved by a healthcare professional as part of the usual clinical routine. Pejvack Motlagh, Medical Director at Genfit, emphasizes that 'in a condition as prevalent as MASH, enabling simple and easily deployable access to a clinically validated test is crucial for identifying at-risk patients earlier in routine practice, particularly in general medicine and endocrinology.' This availability anticipates a possible reimbursement decision by Medicare and Medicaid in the United States.
A Potential Market Estimated at Several Tens of Millions of Patients
The potential patient population in the US targeted by NASHnext is estimated to be several tens of millions of individuals, reflecting the high and growing prevalence of metabolic risk factors in the United States, including type 2 diabetes, obesity, and dyslipidemia. Within this large population, a significant proportion already presents elevated hepatic markers, and a subgroup could eventually be eligible for treatment, with potential additional uses in monitoring. Genfit is actively developing partnerships with pharmaceutical companies to support the broader deployment of non-invasive screening for at-risk MASH and accelerate adoption as therapeutic options expand. It is also exploring the development of an IVD (In Vitro Diagnostic) marked version of its proprietary diagnostic technology, either independently or in collaboration with a specialized diagnostic partner.
