Simple Noninvasive Blood Test Predicts Disease Progression in Patients with Advanced Liver Fibrosis

Nonalcoholic fatty liver disease (NAFLD), if left unchecked, can progress to non-alcoholic steatohepatitis (NASH), a major contributor to liver transplant cases. Early intervention can prevent NASH from progressing to severe fibrosis, a condition that may result in cirrhosis or liver cancer. Currently, doctors use biopsies to detect advanced fibrosis in NAFLD patients, a method that often discourages patients from seeking prompt medical attention. Now, a new test has the potential to address this unmet medical need.

Siemens Healthineers’ (Erlangen, Germany) Enhanced Liver Fibrosis (ELF) Test is the first and only blood test to receive FDA marketing authorization for predicting disease progression in patients suffering from advanced fibrosis due to NASH. Using the ELF Test for prognostic risk assessments allows for the identification of patients who may need further examination, increased monitoring, or modifications in lifestyle and treatment approaches. The test measures liver fibrosis directly, integrating three direct biomarkers: hyaluronic acid (HA), procollagen III amino-terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) through a proprietary algorithm.

Image: The Enhanced Liver Fibrosis (ELF) Test has been granted US FDA Breakthrough Device Designation (Photo courtesy of Siemens Healthineers)

The ELF Test has now earned a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for diagnostic use. This new designation emphasizes the potential broadened use of the ELF Test. Along with other lab results and clinical evaluations, the test could assist in identifying patients with NAFLD who have advanced fibrosis (≥F3) or cirrhosis (F4). The clinical value of the ELF Test is well acknowledged among clinicians. Medical associations in the U.S. have now included its use in their clinical practice guidelines.

"Advanced liver damage due to NASH often goes unrecognized until after liver decompensation, at which point, few interventions are available other than transplant," said Chuck Cooper, chief medical officer of Siemens Healthineers Diagnostics. “Earlier identification creates an opportunity for intervention. In some cases, this may halt or even reverse disease progression. The limited tools available to aid in diagnosis remain the roadblock to earlier patient care. A simple blood test that can help identify high-risk individuals before the disease is clinically evident has the potential for detecting the disease earlier, and subsequent treatment cost savings."

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