Diagnostic and prognostic biomarkers for the screening of patients with metabolic liver disease risk

The spectrum of metabolic liver diseases - the nonalcoholic fatty liver disease (NAFLD) - parallels the prevalence of metabolic syndrome and is associated with the number of its components.1-3 NAFLD is characterized by excessive hepatic fat accumulation (steatosis) and it associates insulin resistance (IR) in the absence of secondary causes and in the absence of excessive alcohol intake (>30 g for men and >20 g for women).4-5 Patients who consume moderate amounts of alcohol may still have a predisposition towards NAFLD in the presence of metabolic risk factors. A recent study has assessed retrospectively a tertiary center cohort, and has shown that the 10-years comparative overall survival of patients with NAFLD was lower than that of patients with chronic hepatitis C (CHC), mainly explained by the fact that patients with NAFLD had older ages, and by the associated non-liverrelated deaths.8 NAFLD overall survival was lower than in chronic hepatitis B (CHB) and higher than in alcoholic liver diseases (ALD). SteatoTest is associated in the FibroMax panel with the FibroTest (APHP-Sorbonne University Patent), the pioneer quantitative marker for the severity of fibrosis, widely validated in subjects with the four most common chronic diseases: CHC and CHB,13 ALD14 and NAFLD.15 The European clinical practice diagnostic flow-chart to assess and monitor disease severity in the presence of suspected NAFLD recommended the use of serum fibrosis biomarkers in subjects having metabolic risk factors and steatosis even with normal liver enzymes. NASH is defined as the presence of both steatosis (5% of hepatocytes or more) and lobular inflammation with hepatocyte injury (e.g., ballooning), with or without fibrosis.4 The non-invasive assessment of inflammation in NASH lacks markers sufficiently validated, most of the existing markers being related to apoptosis or oxidative stress.19 A new quantitative multianalyte test, NashTest 2 (APHP-Sorbonne University Patent) was recently validated permitting to identify more cases of NASH with severe fibrosis compared to the histological definition (NASH-CRN).20 NashTest 2 could be easily combined with FibroTest in order to identify clinically advanced diseases (activity A2 grade or fibrosis F2 stage). [...]for the first time, an activity marker, NashTest-2, has demonstrated significant prognostic values for survival without liver-related death, regardless of FibroTest.8 Liver biomarkers such as FibroTest, SteatoTest, and newly develo