Non-Invasive Liver Diagnostics Pay Off

How to Enable Accurate and Timely Staging of Liver Disease

Claudia Frumento |  Sep 07, 2016

Eight years ago, the Hospital Clinic de Barcelona, a center of excellence for liver transplants in Europe, and Siemens Healthineers – at that time Siemens Healthcare – started a research project on non-invasive diagnostic methods for liver fibrosis.


Photos: Walther Appelt

Executive Summary

  • Cooperative research offers strategic advantages for clinical and industry partners.
  • A cooperation between Hospital Clinic de Barcelona and Siemens Healthineers resulted in a medically and economically highly successful new diagnostic tool for liver fibrosis.
  • The hospital’s integrated core laboratory proved to be a valuable research resource.

Benefits of Combined Non-Invasive Diagnostics
The new approach combines the so-called Enhanced Liver Fibrosis (ELF)1 score, which is based on a set of blood biomarkers, with Acoustic Radiation Force Impulse (ARFI) imaging, which is an ultrasound technology. The integrated analysis can make fibrosis qualification and quantification better and easier, says Dr. Miquel Navasa, who leads the liver transplant program at Hospital Clinic de Barcelona (HCB). Both non-invasive methods provide information on the complete organ.

By contrast, a liver biopsy – which is a diagnostic standard in patients with fibrosis – offers clues only on selected sampling areas, requires hospitalization, and poses a major risk of bleeding. “With the new combined non-invasive diagnostics, we can monitor the disease progression much more closely and can effectively delay it with the required therapy at the right time,” says Dr. Navasa.

Improving Patient Outcomes while Freeing up Resources
Today, the ELF/ARFI approach has been implemented in clinical routine at HCB, avoiding more than 90% of liver biopsies. According to Dr. Navasa, the new diagnostic test is painless and is done on an outpatient basis in a fraction of the time required for a biopsy. This frees up staff and other hospital resources, such as beds and OR facilities.

Dr. Laura Sampietro-Colom, Head of the Health Technology Assessment Unit at HCB, says that the new approach has also had an impact on the healthcare system as a whole. The method has now been implemented at the primary care level in Catalonia. Patients do not have to travel for the routine follow-up, and they are referred to HCB when further treatment or other diagnostic tests are needed. “The cost effectiveness of the new method, which avoids hospitalization and complications, has been shown in modeling studies for Spain as well as for other countries,” says Dr. Sampietro-Colom. “In patients with alcoholic liver fibrosis, the approach actually helps to save money.”


The Lab as a Research Resource

The centrally integrated core laboratory at Hospital Clinic de Barcelona (HCB) hosts one fully automated line that processes 90% of the tests. It is an indispensable resource for clinical routine as well as research.

Its three blood chemistry analyzer systems process 1,700 samples per day, providing blood chemistry information for all patients, including those in clinical studies. Similarly, a powerful immunoassay analyzer for measuring specific biomarkers contributes to the liver fibrosis and tumor research programs at HCB, while a system with chemistry and immunoassay integration provides fast troponin I results for studies on heart failure.

The high degree of automation frees up devices and personnel from other laboratories at HCB, who can thus focus more on specific research projects. Through reduced sample handling and contamination, the automated analyses also help to obtain reproducible results – a prerequisite in any research program.

Enabling Disease Prevention
The combined ELF/ARFI method could also open up new possibilities in disease prevention – such as screening of at-risk groups, which would be ethically unjustifiable with biopsies. “We are seeing an increase in nonalcoholic fatty liver disease, and we believe that this is due to the rising consumption of fast food,” says Dr. Navasa. “With the new diagnostic tool, epidemiological studies are feasible now and we can alert society to dangerous trends. Eventually, we might even see a decrease in the number of liver transplants.”

About the Author

Dr. Claudia Frumento is a freelance medical writer with a PhD in medical information technology and extensive experience in the fields of medical devices, medical communications, and regulatory writing. She is fluent in English, German, and Spanish, and is based in Berlin, Germany.

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1The ELF Test is not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.

The statements by Siemens’ customers described herein are based on results that were achieved in the customer's unique setting. Since there is no "typical" hospital and many variables exist (e.g., hospital size, case mix, level of IT adoption) there can be no guarantee that other customers will achieve the same results.