Humedics receives patent on method for quantitative liver function analysis based on a breath test
Patent is a milestone for further commercialization of the LiMAx test
The Australian patent AU20062664108 covers an analysis method for determining a functional parameter of an organ using a 13C labeled methacetin solution. “This patent is a milestone for the commercialization of our LiMAx test and the corresponding FLIP device”, says Prof. Dr. Karsten Heyne, co‐founder of Humedics GmbH. “We receive so much positive feedback on this test system from clinical users and, from a company perspective, it is great that the essential part of our proprietary technology is protected by now.”
The underlying principle of the test involves the following steps: At first, a 13C methacetin solution is administered intravenously. Methacetin is metabolized in the liver to paracetamol and 13CO2 and the latter is exhaled in the breath. The exhaled air is collected via a respiratory mask. Subsequent measurement of 13CO2 in a detection device provides a quantitative determination of the liver capacity and thus the liver function.
“Liver surgery and liver transplantation often are very serious interventions” says Dr. Martin Stockmann, co‐founder of Humedics GmbH and co‐owner of the mentioned patent. “It is therefore a high medical need to determine liver function prior to this kind of interventions to better assess the prognosis and also after interventions to monitor recovery.” The LiMAx test fulfills these requirements. Liver diagnostic tests available on the market so far are of limited use for this purpose and do not provide a quantitative liver function analysis. The LiMAx test is a bedside test that can be performed prior, during and subsequent to surgery. And the liver surgeon at Charité – Universitätsmedizin Berlin adds: “In liver surgery the LiMAx test provides added value to make correct therapeutic decisions and to improve therapy control.”
The recently granted patent adds to Humedics’ portfolio of pending and granted patents that secures the economic utilization of the company’s products. A previously granted patent covers the measurement device and a method for analyzing a sample gas by infrared absorption (German Patent No 102009055320) and thus Humedics’ FLIP device for the measurement of exhaled air.
Humedics has developed a breath test based in vivo diagnostic system (the LiMAx® test), which comprises a CE-marked medical device, breathing masks and a diagnostic drug. The LiMAx® test enables the clinician to quantitatively determine the individual liver function capacity of a patient within minutes. This allows for selection of treatment strategies and disease monitoring optimally adapted to the individual patients’ liver status. Current clinical applications, studies of which have already been published in highly respected peer-reviewed scientific journals, include diagnosis of the liver function before and after liver transplantation, liver surgery planning (e.g. assessment of the amount of liver to be resected without potentially increasing the risk of acute liver failure) and assessment of diseases such as liver fibrosis and cirrhosis. Over 20 trials in new indications such as the diagnosis of chronic liver diseases like non-alcoholic steatohepatitis (NASH) and the improvement of treatment decisions in liver oncology are ongoing. These investigator initiated trials impressively demonstrate the further potential of the LiMAx® test. The LiMAx® test is already being used in over 30 top-tier university clinics across Europe and more than 20,000 tests have already been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.
Based on the specific metabolic action of the liver enzyme CYP1A2, which is expressed in all functioning hepatocytes, performing the LiMAx® test is a simple procedure. The diagnostic drug solution is administered intravenously, and the liver immediately starts to metabolize the drug into low dose paracetamol and 13CO2 (non-radioactive). The latter is exhaled in the breath, collected via a respiratory mask and guided to the LiMAx® system where, within 1-2 minutes following the injection, the LiMAx® IR laser spectroscopy system allows real-time and very precise quantification of the increase in 13CO2 content. The resulting LiMAx® value, measured in micrograms per kilo body weight per hour, is a reliable and repeatable measure of the maximum functional capacity of the liver.
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