A leading medical technology company, Siemens Healthineers announced that U.S. Food & Drug Administration has granted Breakthrough Device Designation for its ADVIA Centaur Enhanced Liver Fibrosis (ELF®) Test. This ELF blood-based test aids clinicians in assessing the fibrosis stage of chronic liver disease, which could help determine if a patient requires treatment.
The FDA's Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program aims at providing patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review, along with preserving the statutory standards for premarket approval, 510(k) clearance, and protecting and promoting public health.
ADVIA Centaur is an automated random-access immunoassay system that provides a comprehensive testing for infectious diseases, thyroid, fertility and anemia, as well as assays for cancer markers, cardiac analysis, allergy testing and therapeutic drug monitoring. The ELF test analyzes data regarding three serum biomarkers, Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of metalloproteinase 1 (TIMP-1), in an algorithm which provides a single ELF score.
In a company press release, 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. 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 also collaborating with Gilead Sciences, Inc. to seek FDA clearance of this ELF Test.