• Allows for identification of chronic liver disease in patients, including non-alcoholic fatty liver disease (NAFLD).
• Enhanced Liver Fibrosis test service available in 49 states, Washington, D.C., Puerto Rico
Today, Siemens Healthineers announced the availability of its Enhanced Liver Fibrosis (ELF™) testing service* in the United States. The testing service is provided by the Siemens Healthcare Laboratory (SHL), LLC, a unit of Siemens Healthineers that can test samples submitted from all states, Washington, D.C., and Puerto Rico, excluding New York State (pending NY approval).
Using a small, convenient blood sample from a patient, the SHL ELF test provides a simple, unitless numeric score via an algorithm by combining the quantitative measurements in a serum sample of three direct markers of liver fibrosis; hyaluronic acid (HA), amino-terminal propeptide of type III procollagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP-1). This ELF Score can improve patient care by identifying chronic liver disease patients, including non-alcoholic fatty liver disease (NAFLD), and stratifying those at risk of progressing to liver related events i ii .
“Identifying patients with advancing liver fibrosis is a challenge for physicians given the silent nature of the disease. Combined with the increasing burden of liver fibrosis, the demand for efficient, accurate, and safe means testing patients who are at risk of liver-related outcomes becomes increasingly important for helping manage their condition,” says Patrick Joseph, MD, Medical Director of Siemens Healthcare Laboratory. “Our ELF testing service, that measures three direct markers of fibrosis, represents a clinically validated, reliable and convenient testing solution for physicians to help manage patients with progressing liver fibrosis associated with NAFLD and NASH.”
Chronic liver disease, characterized by liver fibrosis leading to cirrhosis and life-threatening liver related outcomes, is caused by viral hepatitis, excess alcohol consumption and metabolic diseases such as non-alcoholic steatohepatitis (NASH) which is a form of non-alcoholic fatty liver disease (NAFLD)iii . The burden and costs of chronic liver disease is increasing dramatically as a result of the high prevalence of NAFLD associated with the obesity epidemic. In the US alone NASH affects around 1.5 to 6.45% of the general populationiv and NAFLD is predicted to be the leading indication for liver transplantation within a decadev. Consequently, there is significant need for convenient, reliable and reproducible blood tests like the SHL ELF testing service that help identify patients with signs and symptoms of chronic liver disease who may progress to potentially life-threatening liver-related outcomes, which can help improve the prediction of NAFLD/NASH and chronic liver disease patients at risk of disease progression.1
“Enabling physicians to both accurately measure as well as prospectively predict liver disease progression is one more way we are expanding precision medicine for our customers and their patients,” said Sebastian Kronmueller, Head of Molecular Services, Siemens Healthineers.
*The ELF testing service has not been cleared or approved by the U.S. Food and Drug Administration. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. The ELF testing service is not available in the state of New York.
i Harrison SA, et al. AASLD 2017. Poster 2122
ii Day J, Patel P, Parkes J, Rosenberg W. Derivation and performance of standardized Enhanced Liver Fibrosis (ELF) test thresholds for the detection and prognosis of liver fibrosis. The Journal of Applied Laboratory Medicine. March 2019
iii https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts
iv Younossi, Z.M. et al., Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology, 2016. 64(1): p. 73-84
v Pais R, Barritt AS 4th, Calmus Y, et al. NAFLD and liver transplantation: Current burden and expected challenges. J.Hepatology. 2016;65(6):1245–1257. doi:10.1016/j.jhep.2016.07.033
Contact for journalists
Lance Longwell
Phone:+1 610-448-6341; E-mail: lance.longwell@siemens-healthineers.com
Siemens Healthineers AG (listed in Frankfurt, Germany, DE: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 diagnostic, image-guided therapy, and in-vivo diagnostics. 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 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion.
Further information is available at www.siemens-healthineers.com.
