Press release

Independent trial shows accurate staging of liver fibrosis with the LiMAx® test

 

Independent trial shows accurate staging of liver fibrosis with the LiMAx® test

Clinical study from the University of Essen reveals superiority of the LiMAx® test for noninvasively detecting different stages of fibrosis and cirrhosis in patients with chronic liver disease

Berlin, Germany, October 24, 2018 – Humedics GmbH, a specialist in real-time measurement of liver function capacity, announced results of a retrospective study that assessed the diagnostic accuracy of the LiMAx® test in patients with chronic liver disease. Results showed that the test can be a useful method to noninvasively determine hepatic disease severity.

Chronic liver disease is a worldwide health issue and a major cause of morbidity and mortality. Inflammatory processes during disease progression lead to increasing stages of liver fibrosis with liver cirrhosis as the terminal disease stage. Since liver tissue can regenerate, early forms of fibrosis are reversible. Therefore, accurate assessment of the fibrosis stages is important for treatment decisions. Reliable detection of cirrhosis is clinically important as this condition increases the risk of developing further complications and liver cancer. Usually a liver biopsy is needed to accurately determine hepatic disease severity and to differentiate fibrosis from cirrhosis. However, this invasive procedure implies risks, is painful for the patient and thus not suited for repeated therapy monitoring.

With the need for a noninvasive method to assess fibrosis and cirrhosis in mind, the Department of Gastroenterology and Hepatology at the University Clinic of Essen conducted a study to evaluate the diagnostic accuracy of the LiMAx® test for this purpose, as well as other methods, such as serum biomarkers and transient elastography in comparison with biopsy-based histological results (classification according to Desmet score). 102 patients with chronic liver disease of different etiologies were included into the retrospective study.

Decreasing liver function as measured by the LiMAx® test showed a strong correlation to the increasing histologically proven degree of fibrosis and the classification of different fibrosis stages. The LiMAx® test was demonstrated to be superior in comparison to other noninvasive methods. In their conclusion, the authors of the study emphasized the added benefits of the LiMAx® test for the noninvasively staging of fibrosis and as a viable alternative to the current standard of care.

Karsten Damgaard-Iversen, CEO of Humedics, commented: “We see a strong and growing interest in our LiMAx® liver function test as liver specialists continue to document its unique value in the diagnosis and clinical management of patients with impaired liver function. The present study impressively demonstrates the accuracy of the LiMAx® test for the noninvasive staging of chronic liver disease and the differentiation of fibrosis from cirrhosis.” PR-326-00 Press Release LiMAx in Fibrosis

 

Erwin de Buijzer, COO of Humedics, continued: “This independent research shows the need for innovative and non-invasive diagnostic liver tests that can complement the current diagnostic tools and fill the void for functional analysis that currently exists in daily clinical practice.”

 

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About Humedics

Based in Berlin, Germany, Humedics GmbH is specialised in rapid and accurate liver function measurement using LiMAx®, an innovative technology for analysing exhaled air. The LiMAx® test provides physicians with a method for quantitatively assessing an individual patient’s liver function capacity within minutes. This enables physicians to select treatment strategies and follow disease progression based on up-to-date knowledge of the functional health of the liver. Current applications, which have already been published in prestigious medical journals, include liver function diagnosis before and after liver transplantation, surgical planning for liver surgery (such as assessing how much liver tissue can be removed without increasing the risk of acute liver failure), and assessment of liver diseases such as fibrosis and cirrhosis.  At present, more than 20 studies regarding new indications are being conducted. These include diagnosing and staging of chronic liver diseases such as non-alcoholic steatohepatitis (NASH), as well as selecting, monitoring and managing different oncology treatment options. These studies, initiated by researchers, have already provided evidence of further potential for the LiMAx® tests. The LiMAx® test is in routine clinical use at more than 30 leading university hospitals in Europe. So far, more than 20,000 LiMAx® tests have been performed. The LiMAx® test is commercially available in Germany, Austria and the UK. 

 

Humedics GmbH

Dr. Ralf Kohnen

Bundesallee 23

10717 Berlin

Tel.: +49 30 6293 955 0

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