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# FDA Looking at MASH Surrogate
- URL: https://www.fdaweb.com/fda-looking-at-mash-surrogate/
- Published: 2025-08-27T12:00:00.000Z
- Updated: 2026-09-14T15:20:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159769

FDA says the CDER Office of New Drugs has accepted an Echosens Letter of Intent to qualify Liver Stiffness Measurement by Vibation-Controlled Transient Elastography as a reasonably likely surrogate endpoint for clinical trials in adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis. An online [statement](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-accepts-proposal-reasonably-likely-surrogate-endpoint-mash-all-cause-mortality-or-liver-related&ved=2ahUKEwicmZ-34KuPAxUXw%5FACHYfsDukQvOMEKAB6BAgVEAE&usg=AOvVaw3whw7Q1my0QxLdb7EPvdaW) says the Letter of Intent indicates the biomarker can predict risk of all-cause mortality or liver-related events in patients with MASH. It offers a non-invasive method for assessing liver stiffness, correlates with liver fibrosis severity, may predict clinical outcomes, and may provide a safer, more accessible approach for monitoring disease progression and treatment response, FDA says.

Accepting the Letter of Intent is the first step in the Drug Development Tool qualification process, in which the company will work with the agency to develop a comprehensive qualification plan for data and validation requirements to support the specific context of use.