Siemens Healthineers’ Enhanced Liver Fibrosis (ELF) Test was granted marketing authorization under the De Novo review pathway.1 The ELF Test, for use with the ADVIA Centaur XP Immunoassay System, provides a simple numeric score that is automatically generated 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 non-alcoholic steatohepatitis (NASH).
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 ultimately lead to cirrhosis and/or liver cancer. Minimally invasive testing is an important tool to help identify NASH patients at risk of progressing to cirrhosis and liver-related clinical events. The Journal of Hepatology states the global prevalence of NAFLD is approximately 25% and is increasing in line with rising prevalence of type 2 diabetes and obesity.2 In the U.S. alone, an estimated 80-90 million individuals currently have diagnosed or undiagnosed NAFLD, of which up to 20 million people could have NASH, with as many as 4-6 million people projected to have advanced fibrosis due to NASH.3 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.
“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,” says Zobair Younossi, MD, MPH, FACP, FACG, AGAF, and expert hepatologist.4
The Chronic Liver Disease Foundation’s recent interim guidance, for example, proposes how the Siemens Healthineers’ ELF Test, in combination with other clinical and laboratory assessments, may be used to identify patients with advanced fibrosis due to NASH at high risk of adverse outcomes.5
“In the United States, there is a need for a simple, noninvasive prognostic test that is convenient, objective, reproducible, accurate, and widely accessible,” says Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. “Our ELF Test, the only IVD assay granted marketing authorization 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.”4,6,7
The ELF Test’s marketing authorization in the U.S. results from a strong clinical and research partnership between Gilead Sciences, Inc. and Siemens Healthineers. Gilead Sciences, Inc. supported the ELF Test De Novo Classification Request throughout the FDA review by providing scientific expertise, clinical study data and resources.
This marketing authorization of the ELF Test follows the Breakthrough Device Designation granted by FDA for the test in November 2018. The FDA’s Breakthrough Devices program is intended to facilitate the development and expedited review of breakthrough technologies to help patients gain more timely access to solutions that potentially provide for more effective treatment or diagnosis for life-threatening diseases for which no approved treatment exists.
1 The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.
2 Younossi, Zobair. Non-alcoholic fatty liver disease – A global public health perspective. Journal of Hepatology. https://doi.org/10.1016/j.jhep.2018.10.033
3 Estes C, Razavi H, Loomba, R, et al. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018;67(1):123-3.
4 Liver biopsy is currently the gold standard for diagnosing NASH and assessing fibrosis. The ELF Test is not for use in the diagnosis of NASH or for the staging of fibrosis. The ELF Test provides prognostic information supplemental to biopsy to assess the likelihood of progression to cirrhosis and liver-related clinical events.
5 Younossi ZM, Noureddin M, Bernstein D, et al. Role of Noninvasive Tests in Clinical Gastroenterology Practices to Identify Patients With Nonalcoholic Steatohepatitis at High Risk of Adverse Outcomes: Expert Panel Recommendations. Am J Gastroenterol. 2021;116(2):254-262.
6 Sanyal AJ, Harrison SA, Ratziu V, et al. The Natural History of Advanced Fibrosis Due to Nonalcoholic Steatohepatitis: Data From the Simtuzumab Trials. Hepatology. 2019;70(6):1913-1927.
7 Younossi, Anstee QM, Wong VWW, et al. The Association of Histologic and Noninvasive Tests with Adverse Clinical and Patient-Reported Outcomes in Patients with Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021;160(5):1608-1619.e13.