
Biome Diagnostics (BiomeDx) is an Austrian MedTech company advancing precision medicine through microbiome profiling. Their flagship product, BiomeOne®, is the world's first stool-based prediction test for immunotherapy (ICI) response in cancer patients, launched in early 2022. BiomeDx combines intestinal microbiome analysis with advanced machine learning and proprietary databases to identify microbial signatures that predict treatment efficacy and potential side effects. The company is ISO 9001 and ISO 13485 certified, highlighting a commitment to quality and safety in medical devices. They aim to integrate their microbiome diagnostics into routine clinical practice to improve cancer care.

Biome Diagnostics (BiomeDx) is an Austrian MedTech company advancing precision medicine through microbiome profiling. Their flagship product, BiomeOne®, is the world's first stool-based prediction test for immunotherapy (ICI) response in cancer patients, launched in early 2022. BiomeDx combines intestinal microbiome analysis with advanced machine learning and proprietary databases to identify microbial signatures that predict treatment efficacy and potential side effects. The company is ISO 9001 and ISO 13485 certified, highlighting a commitment to quality and safety in medical devices. They aim to integrate their microbiome diagnostics into routine clinical practice to improve cancer care.
Founded: 2018
Headquarters: Vienna, Austria
Lead product: BiomeOne® — stool-based test predicting immunotherapy (ICI) response
Certifications: ISO 9001 and ISO 13485
Notable investor event: SanusX acquired ~20% stake (June 2023)
Predicting cancer immunotherapy efficacy and adverse events using intestinal microbiome profiling.
2018
Biotechnology
Listed as a Pre-Seed round on company profiles.
Seed round date reported on company profiles.
six-digit (EUR implied)
FFG grant for immunotherapy biomarker project.
SanusX acquired around a 20% stake as part of a strategic partnership.
“Strategic partnership with SanusX (approx. 20% stake) indicates industry-aligned investor support”