FDA ‘Breakthrough Device’ designation for diagnosis granted for Siemens Healthineers Enhanced Liver Fibrosis Test, signifies progress for nonalcoholic fatty liver disease
The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for the Enhanced Liver Fibrosis (ELF) Test from Siemens Healthineers, signifying a step forward for physicians who currently rely on biopsies for identifying advanced fibrosis in patients with non-alcoholic fatty liver disease (NAFLD).
Prognostic risk assessments using the ELF Test help identify patients who could benefit from additional examinations, whether from increased monitoring, or potential lifestyle changes and treatment interventions. The ELF Test directly measures liver fibrosis and is comprised of three direct biomarkers: hyaluronic acid (HA), procollagen III amino-terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) in a proprietary algorithm.
The new Breakthrough Device Designation underscores the potential expanded utility of the ELF Test—in conjunction with other laboratory findings and clinical assessments in patients with NAFLD—to aid in the identification of advanced fibrosis (≥F3) and cirrhosis (F4).
