Rubió Metabolomics contributes with its OWLiver to the international LITMUS study published in The Lancet, one of the largest prospective evaluations to date of non-invasive biomarkers for metabolic dysfunction-associated steatotic liver disease (MASLD) and its inflammatory form, metabolic dysfunction-associated steatohepatitis (MASH), providing new evidence on OWLiver for the identification of patients with at-risk MASH.
The study included 1,590 participants from 13 countries and evaluated a broad range of biomarkers against centrally assessed liver histology. Among the technologies evaluated was OWLiver, a metabolomics-based blood test developed by Rubió Metabolomics for the non-invasive assessment of MASH and at-risk MASH. The OWLiver analyses included in the study were performed at Rubió Metabolomics’ facilities in Derio, Bizkaia.
In particular, OWLiver-MASEF was evaluated for the identification of at-risk MASH, a population of particular relevance due to the presence of MASH together with significant liver fibrosis. The publication therefore provides new evidence on OWLiver in a large prospective international cohort and contributes to further defining the role of non-invasive biomarkers in identifying patients with higher-risk forms of the disease.
The study also assessed the potential of biomarkers to support clinical trial recruitment. In this setting, OWLiver-MASH showed potential as a prescreening tool for patients with at-risk MASH before confirmatory biopsy.
READ THE PUBLICATION
Vali Y, Wonders K, Lee J, et al. Non-invasive tests in metabolic dysfunction-associated steatotic liver disease: the LITMUS prospective multicentre diagnostic accuracy study. The Lancet. 2026;408:1850–1865. DOI: 10.1016/S0140-6736(26)01145-1
Funding and disclosures
The LITMUS consortium was funded through the Innovative Medicines Initiative 2 Joint Undertaking and by the contributing industry partners. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
