FDA Grants Marketing Authorization to Siemens Healthineers ELF Test for NASH Prognostic Assessment

• The Enhanced Liver Fibrosis (ELF) is the first prognostic tool for patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to be granted De Novo marketing authorization.
• The blood test, for use in patients with advanced fibrosis due to NASH, helps assess the likelihood of progressing to cirrhosis and liver-related clinical events.
• There is a clinical need for a simple noninvasive test that is convenient, objective, reproducible, accurate, and widely accessible.
• This milestone follows the Breakthrough Device Designation FDA granted for the test in November 2018.

Siemens Healthineers announced today that its 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 percent 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," said 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," said 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.

Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company's foundation in in-vitro diagnostics, image-guided therapy, in-vivo diagnostics, and innovative cancer care. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers' ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Following the acquisition of Varian Medical Systems, Inc. the company has approximately 66,000 employees worldwide. Further information is available at www.siemens-healthineers.com.

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