The transition from NAFL to NASH and the stage of fibrosis are important discriminators between a relatively benign prognosis and an increased risk of morbidity/mortality1,3. Liver biopsy remains the established but imperfect ‘gold standard’ investigation being invasive, resource intensive,prone to sampling error and carrying a small but significant risk of complications4. Such invasive tests are not practical outside specialist practice, and are particularly unsuitable with such a large ‘at risk’ population.
A lack of tractable non-invasive biomarkers has impeded the diagnosis, risk stratification and monitoring of patients2. It has also hampered drug development and the conduct of clinical trials, which still depend on histological effect as an endpoint. The overarching aim of LITMUS is to develop, robustly validate and advance towards regulatory qualification biomarkers that diagnose, risk stratify and/or monitor NAFLD/NASH progression and fibrosis stage. Success will help target care to those at greatest risk, facilitate drug development and ultimately give patients access to approved medicines.