Two major international studies have delivered the strongest evidence to date on which non-invasive tests can accurately diagnose and measure the severity of metabolic dysfunction-associated steatotic liver disease (MASLD) and its more severe form, MASH, reducing reliance on liver biopsy.
Published in The Lancet and Nature Medicine , the studies form part of the LITMUS programme, the largest international effort to evaluate diagnostic tools for liver disease.
The main LITMUS Study, published today in The Lancet , assessed blood tests and ultrasound-based liver stiffness measurements in more than 1,500 patients - the largest international study of its kind.
The companion LITMUS Imaging Study, published in Nature Medicine , examined advanced MRI and elastography techniques in more than 350 patients.
Two studies, one comprehensive evidence base: a new benchmark for diagnosing liver disease
Professor Quentin Anstee, Ruth & Lionel Jacobson Chair in Personalised Medicine at Newcastle University, UK, and Honorary Consultant Hepatologist at Newcastle Hospitals NHS Foundation Trust, is joint senior author of both studies and the LITMUS consortium coordinator.
He said: “Together, these two studies give us the most complete picture yet of which diagnostic tests work for liver disease, and how to combine them into a pathway health systems can easily implement.
"For advanced liver scarring and cirrhosis, we now have tools good enough to use with real confidence. Detecting active liver inflammation remains more challenging, but promising non-invasive tests are becoming available."
MASLD affects up to one in three adults worldwide and as many as seven in 10 people living with obesity or type 2 diabetes.
As the first licenced drug treatments for MASH enter clinical practice, there is growing demand for accurate, non-invasive ways to diagnose and monitor disease.
Together, the studies assessed dozens of blood, imaging and elastography-based biomarkers — covering both state-of-the-art and routine diagnostic tests that are already used by doctors — comparing their accuracy to liver biopsy, read by expert pathologists.
The findings provide robust, prospective and independent evidence from large multinational patient cohorts, offering what researchers believe are the most realistic benchmarks yet for non-invasive liver disease testing.
The key findings of the studies are:
Targeting the right patients for referral to specialist liver care
The findings support a simplified diagnostic pathway that, after further validation, could be adopted across healthcare systems: use gamma-GT as an initial screening test, followed by ELF or FibroScan for patients requiring further assessment, with advanced imaging reserved for specialist care.
This approach could help more patients receive an accurate diagnosis without undergoing an invasive liver biopsy while ensuring specialist resources are targeted where they are most needed.
The findings also have important implications for MASH clinical trials.
Because regulators require confirmation of "at-risk MASH" for enrolment in late-stage studies, liver biopsy is likely to remain necessary for now. However, the strong performance of SOMAScan highlights its potential for future adoption.
The LITMUS Imaging Study also demonstrated that elastography techniques performed well for detecting advanced fibrosis and cirrhosis, with MRE outperforming FibroScan-based liver stiffness measurements.
About LITMUS
The Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) programme brought together 53 international partners from academia and industry to develop, validate and assess how accurately biomarkers diagnose and assess the severity of MASLD and MASH, funded through the European Innovative Medicines Initiative 2 Joint Undertaking.
Ends
Notes to Editors
About the two studies
About MASLD and MASH
MASLD (formerly non-alcoholic fatty liver disease [NAFLD], or “fatty liver”) is the most common chronic liver condition worldwide, affecting 25–30% of the population. MASH (formerly NASH), its severe form, can progress to cirrhosis and liver cancer. Two drugs have recently received FDA and EMA approval to treat pre-cirrhotic MASH, with many others in development. The current reliance on liver biopsy makes such studies slow and complicated – once approved by regulators, the use of non-invasive tests is expected to dramatically streamline such studies and will be more acceptable to patients.
Funding and disclosures
LITMUS has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA .
The LITMUS Consortium
Website: https://www.ihi.europa.eu/projects-results/project-factsheets/litmus;
Universities, research organisations, public bodies, non-profit groups
University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom [Coordinator]
Asociacion Centro De Investigacion Cooperativa En Biociencias, Derio Vizcaya, Spain
Assistance Publique Hopitaux De Paris, Paris, France
Consiglio Nazionale Delle Ricerche, Roma, ItalyThird-party
Ethnikon kai Kapodistriakon Panepistimion Athinon, Athina, Greece
European Association For The Study of The Liver, Geneve, Switzerland
Faculdade De Medicina Da Universidade De Lisboa, Lisboa, Portugal
Faculdade de Farmácia da Universidade de Lisboa, Lisboa, Portugal
Fondation Cardiometabolisme Nutrition, Paris, France
Linkopings Universitet, Linkoping, Sweden
Luxembourg Institute Of Health, Strassen, Luxembourg
Orebro University, Orebro, Sweden
Research Triangle Institute, Research Triangle Park, United States
Servicio Andaluz De Salud, Sevilla, Spain
Sorbonne Universite, Paris, FranceThird-party
Stichting Amsterdam Umc, Amsterdam, Netherlands
The University Of Birmingham, Birmingham, United Kingdom
The University Of Nottingham, Nottingham, United Kingdom
Universita Cattolica Del Sacro Cuore, Milano, Italy
Universita Degli Studi Di Firenze, Florence, ItalyThird-party
Universita Degli Studi Di Milano, Milano, Italy
Universita Degli Studi Di Palermo, Palermo, Italy
Universita Degli Studi Di Torino, Torino, Italy
Universitaet Bern, Bern, Switzerland
Universitaetsklinikum Aachen, Aachen, Germany
Universitaetsklinikum Wuerzburg - Klinikum Der Bayerischen Julius-Maximilians-Universitat, Wurzburg, Germany
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz, Mainz, Germany
Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
Universitair Ziekenhuis Antwerpen, Edegem, Belgium
Universite D'Angers, Angers Cedex 01, France
University of Cambridge, Cambridge, United Kingdom
University of Helsinki, Helsingin Yliopisto, Finland
University of Oxford, Oxford, United Kingdom
EFPIA companies
Pfizer Limited, Sandwich, United Kingdom [Industry Lead]
Abbvie Inc, North Chicago Il, United States
Astrazeneca AB, Sodertaelje, Sweden
Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
Bristol-Myers Squibb Company Corp, New York, United States
Eli Lilly And Company LTD, Basingstoke, United Kingdom
Gilead Sciences Inc, Foster City Ca, United States
Intercept Pharma Europe LTD, Bristol, United Kingdom
Novartis Pharma AG, Basel, Switzerland
Novo Nordisk A/S, Bagsvaerd, Denmark
Takeda Pharmaceuticals International AG, Glattpark, Switzerland
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
Antaros Medical AB, Molndal, Sweden
Ellegaard Gottingen Minipigs As, Dalmose, Denmark
Genfit, Loos, France
Ixscient Limited, Twickenham Middlesex, United Kingdom
Nordic Bioscience A/S, Herlev, Denmark
Rubió Metabolomics SLU, Derio, Bizkaia, Spain Perspectum LTD, Oxford, United Kingdom
Somalogic Inc, Boulder Colorado, United States
Other companies
Echosens, Paris, France
Histoindex Pte LTD, Singapore, Singapore
Resoundant, Inc., Rochester, United States
The Lancet
Non-invasive tests in Metabolic-dysfunction Associated Steatotic Liver Disease: The prospective, multi-centre LITMUS Study
29-Oct-2026