The NASHnext assay, powered by GENFIT’s NIS4 technology, is designed to identify patients with at-risk MASH through a blood draw ordered via the Labcorp OnDemand platform.
GENFIT announced that Labcorp’s NASHnext 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 the Labcorp OnDemand platform.
NIS4 was developed to identify patients with at-risk MASH by capturing both disease activity and fibrotic burden, including stage 2 fibrosis. This approach provides data to support clinical evaluation, diagnosis, and treatment decisions, according to a press release from GENFIT.
Addressing Diagnostic Gaps
The availability of the test through an online platform aims to address diagnostic gaps in routine care, according to the company release. While liver biopsy remains the clinical standard for diagnosing at-risk MASH, its use is limited by its invasive nature and cost. Other diagnostic tools, such as blood-based scores, often rely on indirect parameters, and liver imaging can be resource-intensive.
“In a highly prevalent condition like MASH, enabling simple, scalable access to clinically validated testing is essential to identify at-risk patients earlier in routine care, including in primary care and endocrinology settings,” says Pejvack Motlagh, chief medical officer at GENFIT, in a release. “Expanding access must go hand in hand with appropriate clinical oversight to ensure patients are not only tested, but also properly managed based on their results.”
Test Methodology and Access
The NASHnext test evaluates multiple blood-based markers associated with liver fat, inflammation, and liver fibrosis. Unlike standard liver enzyme tests, this methodology analyzes the relationship between several markers.
Through the Labcorp OnDemand interface, patients can order the test online. A healthcare professional reviews all testing requests. Once approved, patients visit a service center for a blood draw and can view results through a mobile application.
The test could potentially serve a US patient population of tens of millions, according to the company. This estimate is based on the growing prevalence of metabolic risk factors such as obesity, type 2 diabetes, and dyslipidemia. GENFIT is currently awaiting a reimbursement decision from Medicare and Medicaid to further expand access.
