Testing for Non-Alcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)

The Enhanced Liver Fibrosis (ELF™) blood test is a simple, accurate, non-invasive test that provides a simple, unitless numeric score that is generated via an algorithm for use in advanced liver fibrosis. It is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-hepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events. Because ELF™ uses a blood sample rather than a biopsy, it can be used routinely for the same patient over time.

FIB-4 index is reported to be a simple, accurate, non-invasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications. It was also reported to be concordant with FibroSure test results.

Based on AACE recommendations, see individual assay descriptions FIB-4 index is calculated first; if FIB-4 index value is between 0 and 1.29, testing stops; if FIB-4 index value is greater than 1.29, testing is reflexed to ELF.

Based on AACE recommendations, see individual assay descriptions FIB-4 index is calculated first; if FIB-4 index value is between 0 and 1.29, testing stops; if FIB-4 index value is greater than 1.29, testing is reflexed to ELF.

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). Quantitative results of 10 biochemicals in combination with age, gender, height, and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.

Utilizing NIS4™ technology, NASHnext™ is a blood-based diagnostic test that quantitatively measures four independent biomarkers to produce a score that identifies, among patients with metabolic factors, those with at-risk NASH, who are at higher risk of disease progression.