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FDA Grants De Novo Authorization for Siemens Healthineers' Enhanced Liver Fibrosis Blood Test

NEW YORK ─ Siemens Healthineers said on Tuesday that the US Food and Drug Administration has granted de novo authorization for the company's Enhanced Liver Fibrosis blood test.

The test, which runs on Siemens Healthineers' Advia Centaur XP immunoassay system, uses three serum biomarkers and provides an algorithm-based numeric score to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis due to non-alcoholic steatohepatitis.

Liver biopsy is the gold standard for diagnosing NASH and assessing fibrosis, and the ELF Test provides prognostic information that supplements a biopsy, Siemens Healthineers said. However, the test is not intended for use to diagnose NASH or for the staging of fibrosis, the firm added.

"In the United States, there is a need for a simple, noninvasive prognostic test that is convenient, objective, reproducible, accurate, and widely accessible," Deepak Nath, president of laboratory diagnostics for Siemens Healthineers, said in a statement.

The ELF Test has been available outside the US for more than 10 years, including in the European Union, Siemens Healthineers noted.

NASH, a type of non-alcoholic fatty liver disease, is characterized by inflammation of the liver and liver cell damage, which can ultimately lead to cirrhosis or liver cancer, or both. Prognostic risk assessments using the ELF Test may be used to help identify patients who could benefit from additional examinations, increased monitoring, and potential lifestyle changes and treatment interventions, Siemens Healthineers said.

The ELF Test’s US marketing authorization stems from a partnership between Gilead Sciences and Erlangen, Germany-based Siemens Healthineers. Gilead Sciences supported the ELF Test de novo classification request by providing scientific expertise, clinical study data, and resources, Siemens Healthineers said.

The de novo authorization follows an FDA Breakthrough Device Designation for the ELF test granted in November 2018.