BiomeOne is the world’s first stool-based response prediction test for immunotherapy (ICI). Based on a single, non-invasive stool sample BiomeOne analyzes the patient’s unique intestinal microbiome signature that provides physicians with clinically actionable information based on the individual microbiome profile of each patient.
BiomeOne identifies patients who will likely benefit (responder) or not benefit (non-responder) from a treatment with checkpoint inhibitor based cancer immunotherapy (CTLA-4, anti-PD-1 or anti-PD-L1). Furthermore, the probability of immune-related adverse events (tolerability) is included in the results. The additional parameters diversity, bacterial richness, and enterotype are scientifically established and serve to improve the overall assessment of the intestinal microbiome of a patient.
BiomeOne and its parameter “clinical response“ fulfils the requirements of the European Directive 98/79 EC for in vitro diagnostic medical devices and is registered as a CE-IVD product. The parameter “tolerability” is Research-Use-Only (RUO).