FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan®) as First Non-Invasive Surrogate Endpoint in MASH Clinical Trials

This milestone opens a path for FibroScan^® to ultimately replace liver biopsy for patient enrollment and treatment response assessment in MASH drug development

WESTBOROUGH, Mass., Sept. 8, 2025 /PRNewswire/ -- Echosens, the leader in non-invasive liver diagnostics, is announcing today that the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), Office of New Drugs has accepted the company's Letter of Intent for the qualification of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography (FibroScan^®) as a reasonably likely surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH).

This is the first time the FDA is accepting the initiation of the qualification process of a non-invasive test as a reasonably likely surrogate endpoint in drug development for MASH—a progressive, advanced form of steatotic liver disease that can lead to cirrhosis, liver cancer, transplantation, or death. In a communication issued by the FDA, Frank Anania, MD, director of the Division of Hepatology and Nutrition in CDER, stated, "This proposal represents an important step toward adopting non-invasive tests in drug development for MASH."

As stated in the Letter of Intent, LSM by VCTE (FibroScan^®) can predict the risk of all-cause mortality or liver-related events in patients with MASH. Acceptance of the Letter of Intent opens a path for FibroScan^® to ultimately replace liver biopsy as the primary endpoint for the interim analysis of trials designed for the accelerated approval of drugs for adults with non-cirrhotic MASH.

Replacing repeated liver biopsies, which are currently used to enroll patients and monitor therapeutic response, with FibroScan^® would ease a significant burden on patients. A FibroScan^® exam takes just a few minutes, is painless, and assesses the liver comprehensively, providing a full picture of liver health that can be repeated as often as needed.

Arun Sanyal, MD, Professor and Director at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, School of Medicine Internal Medicine, Virginia Commonwealth University, said, "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."

This unprecedented acceptance of the Letter of Intent by the FDA is driven by FibroScan's unmatched clinical validation and its use in key pharmaceutical trials in liver drug development, especially for MASH. Recognized worldwide as the leading non-invasive solution for liver health, FibroScan^® is supported by more than 5,600 peer-reviewed publications, including pivotal publications (Gawrieh et al., Journal of Hepatology, 2024, Lin et al., JAMA, 2024, and Mózes et al., Lancet Gastroenterol Hepatol, 2023), showing that changes in LSM by VCTE are associated with liver-related outcomes. Furthermore, FibroScan^® is already the reference point-of-care non-invasive test by all key pharma companies and biotechs conducting MASH trials. Echosens' submission to the FDA included official letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.

For pharmaceutical companies, the acceptance of FibroScan^® as a reasonably likely surrogate endpoint would have the potential to transform drug development in MASH by improving trial recruitment and patient retention. This milestone could accelerate the path to new therapies while helping researchers design safer and more representative, efficient trials. Professor Quentin Anstee, Pro-Vice-Chancellor, Faculty of Medical Sciences 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."

In addition to existing recommendations for FibroScan^® from all prominent guidelines and its preferred position in payer policies, the acceptance of this Letter of Intent by the FDA further strengthens the position of FibroScan^® as the reference non-invasive test to prescribe and monitor MASH treatments—both those already approved and those to come. This milestone also underscores the leadership and ongoing innovation of Echosens, which recently advanced its technology with Guided VCTE in the latest generation of FibroScan^® devices—delivering greater efficiency, automation, and standardization to make liver scanning seamless for all healthcare providers.

About Echosens 
Pioneer in its field, Echosens, significantly changed the practice of liver assessment with FibroScan^®, the non-invasive solution for comprehensive management of liver health. FibroScan^® is recognized worldwide and validated by more than 5,600 peer-reviewed publications, including nearly 220 international guidelines. Echosens has made FibroScan^® available in over 127 countries, enabling millions of liver examinations worldwide. https://www.echosens.com/

Logo - https://mma.prnewswire.com/media/2370966/Logo_Logo.jpg