Aug. 25, 2021—Siemens Healthineers announced that its Enhanced Liver Fibrosis test was granted marketing authorization under the de novo review pathway. The ELF test, for use with the Advia Centaur XP immunoassay system, provides a simple numeric score that is generated automatically 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 nonalcoholic steatohepatitis.
“Our ELF Test, the only IVD assay granted marketing authorization by FDA, measures biomarkers directly involved in the active process of scarring,” Deepak Nath, PhD, president of laboratory diagnostics for Siemens, said in a press statement. “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.”
The FDA granted breakthrough device designation to the test in November 2018.