The first and only biomarker granted FDA De Novo marketing authorization for prognosis of patients with advanced fibrosis due to NASH
The Enhanced Liver Fibrosis (ELF™) Test
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ELF Strongly Recommended in AACE NAFLD Clinical Practice Guidelines
Shortly after the only NASH blood test to be granted De Novo marketing authorization by the FDA in 2021, we are excited to announce that the ELF Test* is now included in the 2022 AACE NAFLD Clinical Practice Guidelines to help stratify NASH patients most at risk for progression to cirrhosis.
NAFLD impacts 25% globally.
20% will progress to NASH.1
Because of the increasing disease burden,
lack of appropriate noninvasive testing
options is a major concern.
Nonalcoholic fatty liver disease (NAFLD) can progress into non-alcoholic steatohepatitis (NASH), which can inflame and damage the liver to the point of advanced fibrosis or cirrhosis, dramatically increasing the patient’s risk of liver failure, liver cancer or even death. These risks can be more than twice as high for people living with diabetes, obesity, or high blood pressure.2
Fatty liver disease is increasing in alignment with the increasing rate of obesity, resulting in an exponential burden of disease consequences and a 178% increase in liver related deaths by 2030.3,4 The road to better outcomes is early and frequent prognostic assessment for disease progression in patients with advanced fibrosis (F3 or F4) due to NASH, as this helps to identify patients who are the most in need of care.
How are you Testing your NASH Patients?
In this video Dr. Arun Sanyal, Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, VCU, discusses why risk-stratification of NASH patients is so important.
The Enhanced Liver Fibrosis Test Guide
The ELF Test Guide
- The ELF Test is the first routine, standardized, direct-biomarker panel for prognostic risk assessment in patients with advanced fibrosis due to NASH.
- ELF is the first and only in vitro diagnostic to be granted De Novo marketing authorization by the FDA for prognosis of patients with advanced fibrosis due to NASH.
- The widely studied ELF Test can assess active, dynamic fibrosis rather than the damage it has caused. This allows the ELF Test to be used as a prognostic marker.
The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.
*In the U.S., the ELF Test is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events. The test is not for use in the diagnosis of NASH or for the staging of fibrosis.
1
Younossi ZM, et al, Arch.cuba.gastroenterol. 2020;1. http://revgastro.sld.cu/index.php/gast/article/view/10/4
2
https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/nonalcoholic-steatohepatitis-information-center/nash-causes-risk-factors/
3Younossi ZM, et al. Global Epidemiology of Nonalcoholic Fatty Liver Disease—Meta-Analytic Assessment of Prevalence, Incidence, and Outcomes Hepatology. 2016;64(1): 73-84
4
Estes C, et al. Fatty Liver Disease Demonstrates an Exponential Increase in Burden of Disease Hepatology. 2018;67:123-133