Siemens Healthineers was granted FDA authorization to market the De Novo product, an Enhanced Liver Fibrosis (ELF) test. The ELF Test, for use with the ADVIA Centaur® XP Immunoassay System, provides a simple numeric score that is automatically generated via an algorithm and is used to improve patient care by assessing the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH).
NASH is a type of non-alcoholic fatty liver disease (NAFLD) and is characterized by inflammation of the liver and liver cell damage, which can ultimately lead to cirrhosis and/or liver cancer. Minimally invasive testing is an important tool to help identify NASH patients at risk of progressing to cirrhosis and liver-related clinical events. The Journal of Hepatology states the global prevalence of NAFLD is approximately 25 percent and is increasing in line with rising prevalence of type 2 diabetes and obesity.2 In the U.S. alone, an estimated 80-90 million individuals currently have diagnosed or undiagnosed NAFLD, of which up to 20 million people could have NASH, with as many as 4-6 million people projected to have advanced fibrosis due to NASH.3 Prognostic risk assessments using the ELF Test may be useful to help identify patients who could benefit from additional examinations, from increased monitoring, and from potential lifestyle changes and treatment interventions.
The ELF test measures biomarkers directly involved in the active process of scarring. Available worldwide for more than 10 years, including in the European Union, this test combines three serum biomarkers to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis due to NASH. Clinicians in the U.S. now have access to a convenient and minimally invasive tool that can enhance their prognostic patient management.