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# Siemens De Novo Granted for Liver Fibrosis Test
- URL: https://www.fdaweb.com/siemens-de-novo-granted-for-liver-fibrosis-test/
- Published: 2021-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:11:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149996

FDA has granted a de novo authorization to Siemens Healthineers for its Enhanced Liver Fibrosis (ELF) Test and its use with the Advia Centaur XP Immunoassay System to provide a simple numeric score that is automatically generated via an algorithm. The test is intended to be 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). It 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, Siemens says.  
  
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 lead to cirrhosis and liver cancer, according to the company. “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,” it says.