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Several blood tests have the potential to reliably detect liver fibrosis and development of cirrhosis at an early stage, according to the international LITMUS study. In the largest and most comprehensive comparison of its kind to date, the research team tested more than 30 biomarkers and test combinations to identify a non-invasive diagnostic option for metabolic dysfunction associated fatty liver diseases. The biomarker thrombospondin-2 (TSP2), which was developed and fully validated by the Institute of Translational Immunology (TIM) at University Medical Center Mainz, proved to be a promising single marker. Oct 30, 2026, 10:27:33 AM Nadine Berger M. Sc. , Universitatsmedizin der Johannes Gutenberg-Universitat Mainz The reliable assessment of metabolic dysfunction-associated steatotic liver disease (MASLD) is crucial for determining the stage of the disease, initiating appropriate treatments, and monitoring the course of therapy. To date, a liver biopsy has often been necessary for this purpose. In this invasive procedure, a tissue sample is taken and examined. Newly developed blood tests have the potential to offer an alternative way to assess liver health, both noninvasively and inexpensively, in the general population in the future.The LITMUS (Liver Investigation: Testing Marker Utility in Steatohepatitis) study provides a comprehensive data foundation for this purpose: It compared 30 individual biomarkers and test combinations for the diagnosis of MASLD and its advanced and progressive stage, known as metabolic dysfunction-associated steatohepatitis (MASH). The study analyzed data from 1,590 patients with MASLD who had been accurately diagnosed via tissue biopsy. The participants were enrolled between 2018 and 2023 at 37 liver centers in 13 countries across Europe and the United States.While none of the tests reached the threshold predetermined in the study for diagnosing early stages of fatty liver disease without significant scarring (fibrosis), several methods performed very well in diagnosing significant liver fibrosis and cirrhosis. In addition to more complex combinations - such as those involving a specialized ultrasound technique (elastography) - the single marker thrombospondin-2 (TSP2) in particular showed good results. It is one of the most promising blood-based markers for assessing progressive and advanced liver fibrosis and inflammation (MASH at risk). TSP2 is a connective tissue protein whose concentration in the blood provides reliable indications of fibrotic changes in liver tissue associated with a risk of developing cirrhosis.University Medical Center Mainz involved in the development and validation of new biomarkersUniv.-Prof. Dr. Dr. Detlef Schuppan, Dr. Sudha Myneni, and Dr. Rambabu Surabattula from the Institute of Translational Immunology (TIM) at University Medical Center Mainz along with Univ.-Prof. Dr. Jorn Schattenberg, who at the time of the study was head of the Metabolic Liver Diseases Division at the Department of Internal Medicine I, played a key role in the development and investigation of this new serum biomarker, TSP2. In the LITMUS study, the TSP2 marker demonstrated significant potential as a single biomarker that is measurable in the laboratory. Compared to complex combination tests, such a single marker could potentially be more easily integrated into existing laboratory workflows, explains Univ.-Prof. Dr. Dr. Detlef Schuppan, Director of the TIM. TIM and the University Medical Center Mainz have previously secured two international biomarker patents together, including TSP2 and TSP2 combined with 2-3 other novel fibrosis markers to assess liver (and lung) fibrosis and their progression. Univ.-Prof. Dr. Beate Straub, Executive Senior Physician at the Institute of Pathology at University Medical Center Mainz, also participated in the research. The results of the LITMUS study now provide an important contribution to the comparative evaluation of diagnostic procedures for fatty liver disease in a large international group of patients.About the LITMUS ConsortiumThe LITMUS Consortium brings together academic research centers and partners from the pharmaceutical and biotechnology industries. The EU project received 34 million euros in funding as part of the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). The projects goal was to develop reliable, non-invasive methods that can improve both patient care and the planning of clinical trials.Background: Metabolic Fatty Liver DiseasesMetabolic dysfunction-associated steatohepatitis (MASLD) is one of the most common chronic liver diseases worldwide. In some affected individuals, this progresses to inflammation of the liver, known as metabolic dysfunction-associated steatohepatitis (MASH). As the disease progresses, liver fibrosis often develops, causing the liver tissue to become increasingly scarred. If this scarring continues, cirrhosis of the liver may develop, which increases the risk of serious complications.To date, the stage of the disease can be reliably determined primarily through a liver biopsy. However, this invasive procedure - in which a tissue sample is taken and examined - can carry risks. Non-invasive tests that provide information about the condition of the liver based on a blood sample are expected to help detect diseases earlier, better assess their severity, and monitor their progression during treatment.About the University Medical Center of the Johannes Gutenberg University MainzThe University Medical Center of the Johannes Gutenberg University Mainz is the only medical institution of supra-maximum supply in the German state of Rhineland-Palatinate and an internationally recognized science location. Medical and scientific specialists at more than 60 clinics, institutes organised in 11 departments work interdisciplinarily to treat around 395,000 patients per year. Highly specialized patient care, research and teaching are inseparably intertwined. Around 3,700 medicine an
