Siemens Healthineers Rolls Out Enhanced Liver Fibrosis Test in U.S.

Siemens Healthineers released its Enhanced Liver Fibrosis (ELF) test, a minimally invasive prognostic tool, in the U.S. following U.S. Food and Drug (FDA) De Novo marketing authorization last August.
 
The blood test assesses prognosis for patients with advanced fibrosis (F3 or F4) from non-alcoholic steatohepatitis (NASH), a non-alcoholic fatty liver disease characterized by liver inflammation. Often called a “silent killer,” NASH patients don’t usually show symptoms until the disease has progressed to the point of severe organ damage.
 
Via a routine blood sample and mathematical algorithm, the ELF test generates a score that assesses disease progression risk. The score can be used to understand likelihood of progression to cirrhosis and other liver-related events. The appropriate interventions and lifestyle changes can then be determined to prevent further 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,” Jennifer Zinn, Head of Diagnostics, North America at Siemens Healthineers told the press. “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.