Siemens Healthineers Launches Enhanced Liver Fibrosis (ELF) Test in the U.S.

• The ELF™ Test is the first and only prognostic blood test granted De Novo marketing authorization to assess disease progression in NASH patients.
• The ELF Test is now available nationwide through collaborations with Labcorp and Quest Diagnostics.

TARRYTOWN, N.Y.–(BUSINESS WIRE)–The Enhanced Liver Fibrosis (ELF) Test from Siemens Healthineers is now available in the United States, providing broad clinical access to the minimally invasive prognostic tool. Currently, the ELF Test is exclusively available through collaborations with Labcorp (NYSE: LH) and Quest Diagnostics (NYSE: DGX), providing access (with a physician’s order) across the country. This is the first time the test is commercially available in the U.S., following De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) in August 2021.

The ELF Test is a simple, effective blood test with proven patient outcomes data to assess prognosis in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease (NAFLD) characterized by inflammation of the liver. NASH affects up to 20 million people in the U.S., and is predicted to be the leading indication for liver transplant by 2030¹. The ELF Test uses a routine blood sample and mathematical algorithm to generate a score that assesses the risk of disease progression. Clinicians can then utilize the score to understand the likelihood of progression to cirrhosis and other liver-related clinical events, and determine the appropriate interventions and lifestyle changes to help prevent further organ damage.

“The availability of the ELF Test at major national reference laboratories brings immediate broad access to patients and clinicians nationwide, providing the best possibility to change the landscape for NASH,” said Jennifer Zinn, Head of Diagnostics, North America at Siemens Healthineers. “At Siemens, our hope is that broad accessibility of the ELF Test will give clinicians and patients a valuable prognostic tool to help catch severe liver damage before it reaches that point. A scan or biopsy can pinpoint current liver damage, which doesn’t necessarily mean the patient will progress to severe disease. With the ELF Test, clinicians can pinpoint the likelihood of future progression, and prescribe the appropriate treatment and lifestyle changes to hopefully mitigate future damage.”

“Now, there is no excuse not to evaluate the prognosis of your patients that have advanced fibrosis due to NASH because this test will become available, hopefully, in all labs in the United States – I see the use for ELF in all of my patients, in combination with other noninvasive tests, and that’s how I’d recommend it to other gastroenterologists and hepatologists,” said Dr. Mazen Noureddin of Cedars-Sinai Medical Center in Los Angeles.

NASH is often called a ”silent killer,” since patients typically don’t exhibit symptoms until the disease has progressed to the point of serious organ damage. Now, with widespread availability of the ELF Test at national reference laboratories, clinicians have access to a convenient and minimally-invasive prognostic tool, which can be tested with a simple routine blood draw.

¹ Estes, C,, Razavi, H., Loomba, R., et al. (2018). Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 67(1):123-33.

For additional information about the ELF Test, please visit siemens-healthineers.us/elf-test.

About NASH

Non-alcoholic steatohepatitis (NASH), is a serious condition, highly associated with obesity and diabetes. NASH causes fat to accumulate in the liver, which leads to inflammation and cell damage. It does not present symptoms until later stages, when serious complications like cirrhosis leave few treatment options for patients. Patients with NASH typically remain undiagnosed because early-stage diagnosis is difficult and expensive. Currently, a visual imaging analysis of a liver biopsy is the only way to diagnose NASH. Surgical biopsy is also an option but is invasive, expensive, painful and may cause serious complications. It also may not provide an accurate picture of the patient’s disease since it only captures a small part of the liver.

Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) pioneers breakthroughs in healthcare. For everyone. Everywhere. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers and its regional companies 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. In fiscal 2021, which ended on September 30, 2021, Siemens Healthineers, which has approximately 66,000 employees worldwide, generated revenue of €18.0 billion and adjusted EBIT of €3.1 billion. Further information is available at www.siemens-healthineers.com.

Contacts

Contact for journalists
Lance Longwell, Siemens Healthineers

Phone: +1 610-883-0788; Email: Lance.Longwell@siemens-healthineers.com