ELF Test can be used with the ADVIA Centaur XP Immunoassay System and provides assessment results in the form of numeric score

Image

FDA Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia.)

Siemens Healthineers has received the US Food and Drug Administration (FDA) marketing authorisation for its Enhanced Liver Fibrosis (ELF) Test, under the De Novo review pathway.

ELF Test is intended for use with the ADVIA Centaur XP Immunoassay System and is designed to provide an automatically generated simple numeric score.

The test uses an algorithm to evaluate the progression of advanced fibrosis due to non-alcoholic steatohepatitis (NASH) to cirrhosis and liver-related clinical events.

NASH is a type of non-alcoholic fatty liver disease, characterised by inflammation of the liver and liver cell damage, which can ultimately lead to cirrhosis and/or liver cancer.

The company said that minimally invasive testing is a key tool to help identify NASH patients at risk of progressing to cirrhosis and liver-related clinical events.

Siemens Healthineers laboratory diagnostics president Deepak Nath said: “In the United States, there is a need for a simple, non-invasive prognostic test that is convenient, objective, reproducible, accurate, and widely accessible.

“Our ELF Test, the only IVD assay granted marketing authorisation by FDA, measures biomarkers directly involved in the active process of scarring.

“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 marketing authorisation for ELF Test was built on a strong clinical and research partnership between Gilead Sciences and Siemens Healthineers.

Gilead Sciences has supported the ELF Test De Novo Classification Request throughout the FDA review by offering scientific expertise, clinical study data and resources.

The marketing authorisation for the ELF test follows the Breakthrough Device Designation granted by the US FDA for the test in November 2018.

Expert hepatologist Zobair Younossi said: “If you just find fat in the liver by ultrasound or an imaging study, that by itself does not mean the patient is going to develop bad liver disease.

“What you must do is find those patients who have the highest chance of progression. So, who are those patients? Those are the patients who have some scarring of the liver. How do we do this today? By liver biopsy. However, things are changing.”