Press release

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Humedics submits marketing authorization application for the diagnostic agent used with the LiMAx test

Application for marketing authorization of the diagnostic agent 13C-Methacetin Solution for infusion used with the LiMAx test

TARDOC Reimbursement Unlocks Major Outpatient Market Opportunity for the LiMAx® Test in Switzerland

Humedics reaches an important commercial milestone: With the introduction of the new Swiss outpatient tariff system TARDOC on 1 January 2026, the LiMAx test® will be  fully reimbursed in the outpatient sector for the first time in Switzerland. This creates a cost-covering, plannable framework for the outpatient use of the test.

An independent analysis confirms a reimbursement of around €970 per test.

The LiMAx test® is the only non-invasive diagnostic that measures dynamic liver function in real time. It improves surgical and therapeutic decisions, reduces complications and treatment duration, and increases efficiency in the healthcare system.

TARDOC replaces the previous TARMED system and better reflects realistic efforts. This will create a regulatory environment that will foster innovation and allow Humedics to expand rapidly in the market. According to CEO Dr. Chalom Sayada, this move marks a turning point for the introduction of the LiMAx test® and is likely to trigger similar developments in other European countries.

160512 Humedics Press Release - Dossier submission.pdf (321.6 KiB)

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About Humedics

Based in Berlin, Germany, Humedics GmbH is specialised in rapid and accurate liver function measurement using the LiMAx® test, 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 diagnostic 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.
 
 

Contact

Humedics GmbH
Bundesallee 23
10717 Berlin
Germany

Phone: +49 30 6293 955 0
info@limaxtest.com
www.limaxtest.com

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