The Enhanced Liver Fibrosis (ELF) Test from Siemens Healthineers is now available in the United States, the company announced.
Currently, the ELF Test is exclusively available through collaborations with Labcorp and Quest Diagnostics. This is the first time the test is commercially available in the U.S., following De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) in August 2021, the company said.
The ELF Test is a blood test to assess prognosis in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease (NAFLD) characterized by inflammation of the liver.
NASH affects up to 20 million people in the U.S., and it is predicted to be the leading indication for liver transplant by 2030, Siemens said, citing research data.
The ELF Test uses a routine blood sample and mathematical algorithm to generate a score that assesses the risk of disease progression. Clinicians can then utilize 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.