Siemens Healthineers11.09.18
The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for the ADVIA Centaur Enhanced Liver Fibrosis (ELF) Test1 from Siemens Healthineers. 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.
Siemens Healthineers is also collaborating with Gilead Sciences, Inc. as part of its work to seek clearance of the ELF Test by the FDA.
The ELF Test would support clinicians, in conjunction with additional clinical evidence, in assessing the fibrosis stage of chronic liver disease through a simple blood test, which may help determine if a patient requires treatment. The ELF Test is designed to analyze 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.
“As cases of liver disease increase, so does the demand for efficient, accurate, and non-invasive diagnostic tools,” said Deepak Nath, Ph.D., president, Laboratory Diagnostics, Siemens Healthineers. “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.”
Currently, no similar blood test has been cleared or approved for clinical use in the U.S. Siemens Healthcare Laboratory is the only clinical laboratory in the U.S. that performs the ELF Test for pharmaceutical therapy clinical trials applications.2
Notes
1 The ELF test is not available for sale in the United States. Product availability may vary by country.
2 ELF testing service exclusively available in the United States for clinical trials testing from Siemens Healthcare Laboratory; The ELF test is not FDA-cleared/approved and not commercially available in U.S. The ELF testing service is for Research Use; not for use in diagnostic procedures.
Siemens Healthineers is also collaborating with Gilead Sciences, Inc. as part of its work to seek clearance of the ELF Test by the FDA.
The ELF Test would support clinicians, in conjunction with additional clinical evidence, in assessing the fibrosis stage of chronic liver disease through a simple blood test, which may help determine if a patient requires treatment. The ELF Test is designed to analyze 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.
“As cases of liver disease increase, so does the demand for efficient, accurate, and non-invasive diagnostic tools,” said Deepak Nath, Ph.D., president, Laboratory Diagnostics, Siemens Healthineers. “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.”
Currently, no similar blood test has been cleared or approved for clinical use in the U.S. Siemens Healthcare Laboratory is the only clinical laboratory in the U.S. that performs the ELF Test for pharmaceutical therapy clinical trials applications.2
Notes
1 The ELF test is not available for sale in the United States. Product availability may vary by country.
2 ELF testing service exclusively available in the United States for clinical trials testing from Siemens Healthcare Laboratory; The ELF test is not FDA-cleared/approved and not commercially available in U.S. The ELF testing service is for Research Use; not for use in diagnostic procedures.
