First Automated Standardised Direct Biomarker Panel for Liver Fibrosis

Siemens Healthcare Diagnostics has announced that its Enhanced Liver Fibrosis (ELF)™ test* has been CE-marked for use on the ADVIA Centaur® Immunoassay Systems. This first fully automated standardised direct biomarker panel offers clinicians a quick, reliable, minimally invasive blood test option to assess liver fibrosis – a leading indicator of Chronic Liver Disease (CLD) – with results in less than one hour.

With the addition of the ELF test, Siemens is currently the only company to offer an integrated portfolio of diagnostic solutions for managing liver health, which includes routine chemistry tests, hepatitis serology tests, viral load testing, and ultrasound systems.

Liver fibrosis is an important indicator of CLD, such as cirrhosis and liver cancer, which are now among the top ten causes of death worldwide. i ii The ELF test is a simple, standardised blood test that assesses the severity of liver fibrosis by combining three direct serum biomarkers - hyaluronic acid (HA), procollagen III amino terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) - in an algorithm. The result is an ELF score, which correlates to the level of liver fibrosis assessed by liver biopsy,iii the current standard of care for liver fibrosis diagnosis.

“The discovery of the ELF markers represents a significant advance in the diagnosis of patients with liver disease,” said William Rosenberg, MBBS, D. Phil, Peter Scheuer Chair in Liver Diseases Joint Director of the Centre for Hepatology University College London. “Of particular benefit, the ELF test can help to identify patients with mild-to-moderate liver fibrosis, which is usually asymptomatic, so that clinicians are able to intervene before significant damage to the liver occurs.”

“While liver biopsy is the standard for assessing liver fibrosis, unfortunately, there are challenges with this procedure, including patient discomfort and difficulties in interpreting the results,” explains Dave Hickey, CEO, Chemistry, Immunoassay, Automation, and Diagnostics IT Business Unit at Siemens Healthcare Diagnostics. “By offering an automated, routine, minimally invasive blood test, Siemens provides an additional tool to physicians to aid them to easily assess the severity of liver fibrosis in their patients with chronic liver disease.”

The ELF test has been clinically validated on an Immuno-1 auto analyzer in an international multi-centre study with a mix of patient groups, including viral hepatitis, non-alcoholic fatty liver disease (NAFLD), and alcoholic patient groups. Additionally, a 7-year follow-up study involving over 450 patients has shown that the ELF markers are at least comparable to liver histology at predicting clinical outcomes of CLD.iv

For more information about the Siemens ELF Test, visit the company article page.