---
title: >-
  Relationship between non-invasive tests, clinical outcomes and liver biopsy
  among people with MASH under real-world conditions.
description: >-
  Explore this publication on real-world evidence: Relationship between
  non-invasive tests, clinical outcomes and liver biopsy among people with MASH
  under…
date: '2025-01-01'
category: Publications
tags:
  - Paris MASH Meeting
  - Poster Presentation
  - Approval / Commercialization
  - Care
  - Hepatology
  - MASH/MASLD
  - Pharma Partner
  - Health System Partner
canonical_url: >-
  https://www.pedestalhealth.com/resources/publications/paris-nash/relationship-between-non-invasive-tests-clinical-outcomes/
source: Pedestal Health
license: © 2026 Pedestal Health. All rights reserved.
slug: relationship-between-non-invasive-tests-clinical-outcomes
id: 6bYIRLyjtaQUHWwwDqGvkb
contentType: article
---

## Challenge

While liver biopsy remains the reference standard for MASH assessment, the relationship between biopsy-derived histological change and actual incidence of clinical outcomes in real-world patients—and whether non-invasive FIB-4 changes track those outcomes equivalently—had not been established at scale.

## Solution

A TARGET-NASH analysis using patients with paired biopsies and serial FIB-4 measurements assessed the association between FIB-4 category transitions and the incidence of cirrhosis, decompensation, and composite clinical events, providing direct real-world validation of FIB-4 as a clinical outcome surrogate.

## Impact

Establishing that FIB-4 category worsening predicts clinical outcomes with similar directionality to histological progression supports the regulatory acceptability of NIT-based endpoints and directly addresses the long-standing challenge of linking non-invasive markers to meaningful clinical events in MASH trials.

### [Breda Munoz](/people/breda-munoz/)

![Breda Munoz, PhD — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/3H1T2mfvSNFj6w9tulnreq/a74ae05fe53e400f176d4e9c617b8fb8/breda-munoz.jpg)

### [Andrea R. Mospan](/people/andrea-mospan/)

![Andrea R. Mospan, PhD, RAC — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/4w6bkwPHPqrXKYs4tHZPkK/1d21763b54ecc3466764986693b7072f/andrea-mospan.jpg)

### [Heather L. Morris](/people/heather-morris/)

![Heather Morris, PhD — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/16PnQ817q7tv964vhcUD5f/ce6797c32df11f022ef12ecbb9ffea49/heather-morris.jpg)