FDA Acceptance Marks a Milestone for FibroScan® in Non-Invasive Liver Diagnostics

On September 8, 2025, Echosens, a leader in non-invasive liver diagnostics, announced a significant achievement: the U.S. Food and Drug Administration (FDA) has accepted the company’s Letter of Intent. This letter seeks to qualify the Controlled Transient Elastography (VCTE) measurement through its FibroScan® device as a surrogate endpoint in clinical trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH). This unprecedented acceptance could pave the way for replacing invasive liver biopsies in patient recruitment and treatment response evaluations during drug development.

The FDA's acceptance is a landmark event, marking the first time a non-invasive test has been recognized by the FDA as a reasonably likely surrogate endpoint in drug development for MASH, a progressive liver condition that could lead to cirrhosis, liver cancer, transplantation, or even death. Dr. Frank Anania, director of the Division of Hepatology and Nutrition at the Center for Drug Evaluation and Research (CDER), stated, “This proposal represents an important step toward adopting non-invasive testing in drug development for MASH.”

The Letter of Intent outlines that the Liver Stiffness Measurement (LSM) via VCTE (FibroScan®) can predict mortality risk and liver-related events in MASH patients. The FDA's acceptance facilitates FibroScan®'s potential to replace liver biopsies as the primary endpoint in studies designed for fast-tracking drug approvals for non-cirrhotic adults with MASH.

Switching from invasive, repeat liver biopsies to FibroScan® would significantly reduce patient burden. The FibroScan® examination is quick, painless, and provides comprehensive insights into liver health that can be repeated as necessary.

Dr. Arun Sanyal, a leading expert at the Stravitz-Sanyal Institute for Liver Diseases and Metabolic Health at the Virginia Commonwealth University School of Medicine, emphasized the significance of this development. He stated, “The acceptance of this Letter of Intent marks an important milestone, grounded in years of clinical research and publications, with far-reaching implications for the field, expected to accelerate drug development and be readily translatable to clinical practice.”

This groundbreaking acceptance by the FDA is attributed to the unmatched clinical validation of FibroScan and its application in key pharmaceutical trials for liver drug development, particularly for MASH. Recognized globally as the leading non-invasive solution for liver health, FibroScan® is supported by more than 5,600 peer-reviewed publications, demonstrating that changes in LSM through VCTE correlate with liver outcomes. Furthermore, FibroScan® is already the reference non-invasive test at the point of care for all major pharmaceutical and biotechnology companies conducting MASH trials. The submission to the FDA included official letters of support from major industry players such as Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.

For pharmaceutical companies, acceptance of FibroScan® as a reasonably likely surrogate endpoint could transform drug development processes for MASH, enhancing patient recruitment and retention in clinical trials. This milestone is expected to expedite the development of new therapies while aiding researchers in designing safer, more representative, and efficient trials. Professor Quentin Anstee from the University of Newcastle's Faculty of Medical Sciences noted that this acceptance is a crucial first step for non-invasive tests to be adopted as reasonably likely surrogate endpoints in MASH clinical trials. It serves as a clear signal for all pharmaceutical sponsors to collect robust data from non-invasive biomarkers in their ongoing or future clinical trials on MASH.

In addition to existing recommendations for FibroScan® in all major clinical guidelines and its preference in insurance policies, the FDA's acceptance further solidifies FibroScan®’s position as the reference non-invasive test for prescribing and monitoring MASH treatments, both established and emerging. This achievement also highlights Echosens’ ongoing leadership and innovation, having recently enhanced its technology with VCTE-guided advancements in the latest FibroScan® devices, offering greater efficiency, automation, and standardization for liver exploration among healthcare professionals.

About Echosens

Echosens has revolutionized liver evaluation practices with FibroScan®, a non-invasive solution for comprehensive liver health management. FibroScan® is globally recognized and validated by over 5,600 peer-reviewed publications, including nearly 220 international guidelines. Echosens has made FibroScan® available in over 127 countries, facilitating millions of liver examinations worldwide.