Microbiota Analysis for Immunotherapy

The first test to support the prediction of the response to cancer immunotherapy based on the microbiota

What is BiomeOne?

BiomeOne is the first test CE-IVD on fecal sample which can provide support in forecast of the response to immunotherapy (Immune Checkpoint Inhibitors, ICI).

On a simple stool sample, the laboratory performs the BiomeOne test, which determines the patient's intestinal microbiota and provides three types of information:

1) Clinical Response
BiomeOne can identify patients who are most likely to benefit (responders) or not (non-responders) from treatment with anti-tumor immunotherapy with ICIs (e.g., CTLA-4, anti-PD-1, or anti-PD-L1).  The BiomeOne test and its parameter “Clinical Response” meet the requirements of the European Directive 98/79 CE for in vitro diagnostic medical devices. The test result therefore provides potentially useful information when choosing a therapeutic option based on the patient's microbiota profile.

2) Tolerability (irAEs)
Additionally, the BiomeOne test results include the parameter “Tolerability”, that is, the likelihood that the patient will experience adverse events related to immunotherapy (immune-related adverse events, irAEs).  The “Tolerability” parameter is for research-use only (RUO).

3) “Diversity“, “Bacterial richness" And "Enterotype“
These three parameters are scientifically consolidated and can contribute to the overall assessment of the patient's intestinal microbiota.

Intended Use (in English) 

Example of report (in English)

Please note: The results described in the BiomeOne report are intended as additional information for the treating physician and should not be used as the sole basis for any treatment decision.

More accurate prediction of clinical response

BiomeOne® has a prediction sensitivity of >80% based on samples from cancer patients across Europe and the United States.

The prediction is better than 20% compared to the PD-L1 expression assay (sensitivity ~65%).

BiomeOne is based on data from more than 10,000 patients with non-small cell lung cancer, renal cell carcinoma, and malignant melanoma.

Single sample, non-invasive

Only one stool sample is needed to perform a thorough microbial DNA analysis.

Validated and certified

BiomeOne has been validated as part of a clinical study* with 80 patients with advanced cancer (NSCLC, RCC, Melanoma). The test is a CE-marked in vitro diagnostic, performed in the laboratories of the Austrian company Biome-Dx.

 * I. Robinson et al. Assessing the Performance of a Novel Stool-Based Microbiome Test That Predicts Response to First Line Immune Checkpoint Inhibitors in Multiple Cancer Types. Cancers (Basel). 2023 Jun 21;15(13):3268. doi: 10.3390/cancers15133268.