A leading medical technology company, Siemens Healthineers recently announced that it has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its ® Enhanced Liver Fibrosis (ELF®) Test. FDA's Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Designed to set a new standard for liver fibrosis assessment, the Adiva Centaur ELF® is a blood-based test that helps clinicians assess the fibrosis stage of chronic liver disease, which could help determine if a patient requires treatment. This routine blood test provides an ELF Score that delivers information on liver fibrosis severity. The test uses an algorithm and provides a single ELF score by analyzing three serum biomarkers - hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase 1. It provides results quickly, allowing for proper clinical treatment of patients at risk for severe liver disease.
Deepak Nath, Ph.D., President, Laboratory Diagnostics, Siemens Healthineers said, "As cases of liver disease increase, so does the demand for efficient, accurate, and non-invasive diagnostic tools. Siemens Healthineers is committed to improving the patient experience for those with chronic liver disease, of which Non-Alcoholic Fatty Liver Disease (NAFLD) accounts for the majority of cases, by seeking a non-invasive prognostic tool to assess the risk of progression to cirrhosis and liver-related clinical events."
No similar blood test has been cleared or approved for clinical use in the U.S. currently and Siemens Healthcare Laboratory is the only clinical laboratory in the U.S. that performs the ELF Test for pharmaceutical therapy clinical trials applications. The company is collaborating with Gilead Sciences to seek clearance of the ELF test by the FDA.