MASHtrack is a retrospective cross-sectional study. The study will leverage previous-collected serum from a cohort of subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) and the full spectrum of disease. These subjects were followed for a medium duration of 10+ years and the accompanied liver-associated clinical events (LACE). The cohort will cover the full spectrum of disease. The MASHtrack project team will principally use samples from patients enrolled in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) nonalcoholic steatohepatitis clinical research network (NASH CRN) database 2 study or baseline samples from those who participated in placebo arms of clinical trials for adults with metabolic dysfunction-associated steatohepatitis (MASH). These biomarker values from these samples will be related to the incidence of clinical events during follow up. This research is expected to inform how the biomarkers will be used in clinical practice.

  • Assess the performance of each pre-identified, analytically robust, fit-for-purpose, non-invasive circulating biomarker to predict the likelihood of LACE in patients with MASLD and MASH.

  • Test whether the biomarkers being developed as diagnostic tools for fibrosis provide superior prognostic information over and above that provided by existing clinical tools such as the Fibrosis-4 score.

  • If successful, the results will provide a dataset to contribute towards and support a Letter of Intent (LOI) to the FDA Biomarker Qualification Program for MASH prognostic biomarkers




In development


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