Two large-scale international studies have found that non-invasive tests can detect metabolic dysfunction-associated steatotic liver disease (MASLD), its more severe form \u2014 metabolic dysfunction-associated steatohepatitis (MASH) \u2014 and advanced fibrosis with high accuracy. According to findings published in The Lancet and Nature Medicine, this approach significantly reduces the need for invasive liver biopsies.<\/p>\n
Both papers are part of LITMUS, the largest international programme evaluating diagnostic tools for liver disease. Researchers examined dozens of routine and emerging blood, imaging and elastography biomarkers, comparing their accuracy with liver biopsy results assessed by expert pathologists. In the study published in The Lancet, scientists analysed the performance of blood and ultrasound tests in more than 1,500 patients, while the Nature Medicine study evaluated advanced magnetic resonance (MR) and elastography techniques in more than 350 patients.<\/p>\n
The researchers found that the highest diagnostic accuracy for advanced fibrosis (scarring) and cirrhosis was achieved using a proteomic panel (SOMAScan), magnetic resonance elastography (MRE) and FibroScan-based tools, including the Agile 3+ score. Furthermore, when comparing imaging methods, MRE performed better than FibroScan. For the detection of cirrhosis specifically, the blood tests ELF and ADAPT exceeded the predefined diagnostic thresholds.<\/p>\n
The authors also identified an important trend in primary screening. In routine clinical practice, the inexpensive and straightforward gamma-GT blood test provided more accurate results in the initial assessment of the disease than the widely used FIB-4 index. As for identifying \u201cat-risk MASH\u201d, the key target population in clinical trials, only the SOMAScan panel met the established accuracy threshold. Since regulatory authorities require accurate confirmation of this diagnosis when enrolling patients in late-stage clinical trials, biopsies will temporarily remain necessary in this setting. However, the SOMAScan results point to its potential for future use.<\/p>\n
According to Professor Quentin Anstee of Newcastle University, coordinator of the LITMUS consortium, these two studies provide a comprehensive picture of which diagnostic tests actually work. He added that doctors can already use existing non-invasive tools with considerable confidence to detect advanced fibrosis and cirrhosis, although identifying active liver inflammation remains a challenge.<\/p>\n
Based on these findings, the authors propose a simplified diagnostic algorithm for clinical practice: using the gamma-GT test for initial screening, ELF or FibroScan methods to confirm disease severity, and specialised, advanced imaging techniques in complex cases.<\/p>\n
This new approach could spare patients painful biopsies while directing specialised medical resources where they are most needed. Furthermore, as the first licensed medicines for MASH are already being introduced into clinical practice, accurate non-invasive diagnosis and monitoring of the disease are becoming critically important.<\/p>\n
For context, MASLD affects approximately one in three adults worldwide and seven out of ten people with obesity or type 2 diabetes.<\/p>\n