Novel clinical biomarker for hepatic steatosis

The worldwide rise of obesity and metabolic syndrome has ledto an increasing prevalence of nonalcoholic fatty liver disease. A subset of the one-quarter of affected patients globally have nonalcoholic steatohepatitis, which is an inflammatory disease that often advances to cirrhosis and end-stage liver failure. The enormous number of affected patients is accompanied with substantial morbidity, mortality and healthcare costs, presenting an emerging clinical challenge. The worldwide rise of obesity and metabolic syndrome has led to an increasing prevalence of nonalcoholic fatty liver disease. A subset of the one-quarter of affected patients globally have nonalcoholic steatohepatitis, which is an inflammatory disease that often advances to cirrhosis and end-stage liver failure. The enormous number of affected patients is accompanied with substantial morbidity, mortality and healthcare costs, presenting an emerging clinical challenge.

Shedding of CD46 from hepatocytes into circulation reflects a stress response of hepatocytes to fat loading, which appears to be connected with activation of innate-like lymphocyte responses; therefore, soluble CD46 is unlike other established clinical liver markers by measuring a different type of hepatocyte property indicating cell injury, synthetic function, detoxifying activity, fibrosis or systemic inflammation. Soluble CD46 is a promising clinical marker of patients with steatosis at risk of developing early liver inflammation, a prevalent subset that could benefit from earlier clinical detection and intervention.

- Applicable as an alternative or complement for detecting or grading hepatic steatosis

- Fast, simple and inexpensive compared to resource-intensive imaging methods

- Minimal non-invasive diagnostic tool - no need for liver biopsy

- Validation via immuno-competition assay - other immunological assays possible, e.g. ELISA

TRL Level 6: Technology demonstrated in relevant environment