Jan. 26, 2022—Siemens Healthineers’ Enhanced Liver Fibrosis test is now available in the United States. It is the first time the test has been commercially available in the U.S., following FDA de novo marketing authorization in August 2021, and is available through collaborations with Labcorp and Quest Diagnostics.
The ELF test is a routine blood test used to predict progression to cirrhosis and liver-related events in patients with nonalcoholic steatohepatitis (NASH) with advanced fibrosis (F3 or F4). The test uses a mathematical algorithm to generate a score that assesses the risk of disease progression. Clinicians can use the score to understand the likelihood of progression to cirrhosis and other liver-related clinical events and determine the appropriate interventions and lifestyle changes to help prevent further organ damage.