Siemens Healthineers Gets FDA Approval to Market Its Enhanced Liver Fibrosis Test
Siemens Healthineers’ Enhanced Liver Fibrosis (ELF) test has received marketing authorization from the FDA under the de novo device review pathway.
The test is designed for patients with non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease characterized by inflammation of the liver and liver cell damage, which can lead to cirrhosis and/or liver cancer.
The minimally invasive test is designed for use with Advia’s Centaur XP immunoassay system. It generates a numeric score via an algorithm to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis due to NASH.