VIENNA, July 2022: Vienna-based Biome Diagnostics launches the first and only gut microbiome-based predictive test to date, BiomeOne®. The test analyzes and evaluates the response to immunotherapy (ICI) against cancer and the likelihood of side effects. Clinical studies have confirmed its efficacy. BiomeOne® is certified and approved as a medical device (CE-IVD).
Immunotherapy supports the body’s own immune system in fighting cancer cells. Especially the so-called immune checkpoint inhibitors (ICIs) are causing great confidence among physicians: Compared to chemotherapy, ICIs have so far greatly improved the overall survival rates of patients. However, for a large number of patients, their use is associated with severe side effects, such as fatigue, nausea, vomiting, skin reactions, or the development of autoimmune diseases. This is particularly dramatic if the treatment does not work – which is the case for about 60-70% of patients (depending on the type of cancer). With BiomeOne®, unnecessary suffering can now be prevented and valuable time can be gained for successful therapy.
With the predictive test, the bacterial composition in the intestine can be analyzed, because it has a decisive influence on the body’s immune response. The results are evaluated with the help of artificial intelligence. Doctors then know whether the person concerned will respond to therapy and how likely it is that serious side effects will occur. Only one stool sample is needed. BiomeOne® has a prediction accuracy of over 80 percent, based on clinical studies at leading hospitals such as the Department of Internal Medicine and Pneumology at the Floridsdorf Clinic, the Medical University of Vienna, the Medical University of Innsbruck and the Medical University of Graz.
Prim. Priv.-Doz. Dr. Arschang Valipour, Principal Investigator of the validation study as well as Head of the Karl Landsteiner Institute for Lung Research and Pneumological Oncology, Vienna, about the biomarker: “BiomeOne® is a promising biomarker in oncology. By targeting the gut microbiome and further developing this platform, we are one step closer to the goal of personalized medicine in the treatment of oncological disease patterns.”
“For the first time, it is possible to use the gut microbiome to determine response to cancer immunotherapy. This is revolutionary. Especially for patients it is a great relief because it is a non-invasive method,” explains Dr. Barbara Sladek, Founder and Managing Director of Biome Diagnostics.
“The importance of the gut microbiome for health has been known scientifically for some time. Now, for the first time, it has been possible to use the gut microbiome for oncological diagnostics. This is a significant step for further personalization of cancer immunotherapies,” said Dr. Nikolaus Gasche, Founder and Managing Director of Biome Diagnostics.
Biome Diagnostics combines state-of-the-art DNA sequencing with artificial intelligence to drive the evolution towards better, less suffering cancer therapies. The company’s goal is to establish the gut microbiome in cancer medicine.
Cancer is considered the second most fatal disease. The Robert Koch Institute estimates that around 500,000 people are diagnosed with cancer each year in Germany. According to forecasts, new cases of cancer will increase by up to 23 percent by 2030 due to demographic change. In addition, there is insufficient early detection and deficiencies in the treatment itself. Timely and widely used methods of cancer diagnosis can therefore prevent suffering for patients and high costs for the healthcare system.