NEW YORK (360Dx) – Siemens Healthineers said today that the US Food and Drug Administration has granted Breakthrough Device designation for its Advia Centaur Enhanced Liver Fibrosis (ELF) test.
Along with other clinical evidence, the ELF blood-based test aids clinicians in assessing the fibrosis stage of chronic liver disease, which could help determine if a patient requires treatment, Siemens Healthineers said. 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.
The FDA’s Breakthrough Devices program is intended to facilitate the development and expedite the review of breakthrough technologies to help patients gain more timely access to solutions that potentially provide for more effective treatment or diagnosis for life-threatening diseases for which no approved treatment exists.
"As cases of liver disease increase, so does the demand for efficient, accurate, and noninvasive diagnostic tools," Deepak Nath, president of laboratory diagnostics at Siemens Healthineers, said in a statement.
Currently, no similar blood test has been cleared or approved for clinical use in the US. Siemens Healthineers said that it has the only clinical laboratory in the US that performs the ELF Test for pharmaceutical therapy clinical trials applications. The ELF testing service is for research use and not for use in diagnostic procedures, the firm said.
Siemens Healthineers noted that it is collaborating with Gilead Sciences to seek clearance of the ELF test by the FDA.