Echosens, a global leader in non-invasive liver diagnostics, announced that the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Office of New Drugs, has accepted its Letter of Intent to qualify Liver Stiffness Measurement (LSM) by Vibration-Controlled Transient Elastography (VCTE) using FibroScan® as a reasonably likely surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH).
This marks the first time the FDA has agreed to begin the qualification process for a non-invasive test as a surrogate endpoint in drug development for MASH—a progressive form of liver disease that can lead to cirrhosis, cancer, transplant, or death.
In a communication from the FDA, Frank Anania, MD, Director of the Division of Hepatology and Nutrition in CDER, noted:
"This proposal represents an important step toward adopting non-invasive tests in drug development for MASH."
According to the Letter of Intent, LSM by FibroScan® can predict all-cause mortality or liver-related events in MASH patients. Its acceptance paves the way for FibroScan® to potentially replace invasive liver biopsies as the interim endpoint for accelerated approval trials in non-cirrhotic MASH.
Unlike repeated liver biopsies, FibroScan® is painless, quick, and provides a complete assessment of liver health—allowing frequent monitoring without patient burden.
Arun Sanyal, MD, Professor and Director at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, emphasized:
"The acceptance of this Letter of Intent is a major milestone, built on years of clinical research and publications, together with the tireless efforts of numerous stakeholders across the field, with major implications for the field and is expected to accelerate drug development and also be easily translatable to clinical practice."
FibroScan®’s unmatched validation underpins this milestone. Supported by over 5,600 peer-reviewed studies—including pivotal publications (Gawrieh et al., Journal of Hepatology, 2024; Lin et al., JAMA, 2024; Mózes et al., Lancet Gastroenterol Hepatol, 2023)—the device has already become the reference non-invasive test in major MASH drug trials. Echosens’ FDA submission was further reinforced by letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.
For pharma companies, FDA acceptance could reshape MASH drug development—streamlining recruitment, boosting retention, and enabling safer, more efficient trials.
Professor Quentin Anstee, Pro-Vice-Chancellor at Newcastle University, stated:
"The FDA accepting this letter of intent is a critical first step to ultimately have non-invasive tests adopted as reasonably likely surrogate endpoints in MASH clinical trials. It's a clear signal to all pharma sponsors to collect robust non-invasive biomarker data in their ongoing or future clinical trials in MASH."
Already endorsed by leading clinical guidelines and payers, FibroScan®’s role is further strengthened by this FDA decision. Echosens continues to innovate with Guided VCTE technology in the latest FibroScan® generation—bringing greater automation, efficiency, and consistency for healthcare providers worldwide.