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World’s first microbiome based response prediction test for immunotherapy

What is BiomeOne?

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 ā€œclinical responseā€œ 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 ā€œtolerabilityā€ is Research-Use-Only (RUO).


2 weeks from receipt of stool sample


Melanoma, non-small cell lung cancer, renal cell carcinoma


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More accurate response prediction

Currently, BiomeOneĀ® has a prediction sensitivity of >80% based on samples from cancer patients across Europe and the US. The prediction is 20% better than with PD-L1 expression testing (sensitivity ~65%).

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

Non-invasive, single sample

Only one stool sample is required to perform a thorough microbial DNA analysis and predict the probability of response to cancer immunotherapy for an individual patient.

Medically validated and certified

Separately from the test development, BiomeOne was validated as part of a clinical study in 80 late-stage cancer patients. The test is a CE marked in vitro diagnostic to be used on the European market. Further international regulatory certifications are pending.

Microbiome diagnostics is certainly one of the most promising research areas of our time. BiomeOne should provide us with deeper insights into the interaction between the body's own microbiome and cancer immunotherapy. This could help us in the future to tailor cancer treatment more specifically to affected patients and to individualize the risk-benefit profile of the therapy as much as possible.

Prim. Doz. Dr. Arschang ValipourHead of Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Austria

How to order a BiomeOne test?


Place an order

Place a test order online by logging in or signing-up for a BiomeDx Platform account. Complete the order form, including the address and provide any required details of the patient and submit.


Sample taking

Biome Diagnostics will ship the sampling kit to the address (either hospital or patient's home) for sample taking. The patient takes a stool sample with the provided materials and ships it back to our laboratory with the prepared envelope.

Laboratory and bioinformatic analysis

We perform DNA sequencing of the gut bacteria to identify every organism in the stool sample. Our proprietary microbial signature allows to calculate the response and tolerability parameters.

Receiving results

You will receive online or per email results typically 14 days or less from receipt of sample for BiomeOne. The report includes comprehensive information to support the individual treatment decision.
Access the BiomeDx Platform

Signup on the BiomeDx Platform

Place an order for a new BiomeOne analysis immediately on the BiomeDx Platform. The test kit is sent out on the same day.

Access the BiomeDx Platform

Or get in touch with our team

We are happy to answer your questions and help you out.

Frequently asked questions

What is BiomeOne?

BiomeOne is a cloud-based in vitro diagnostic software intended for the detection of responders and non-responders to checkpoint inhibitor based cancer immunotherapy (CTLA-4, PD-1, PD-L1) based on stool microbiome profiles of late-stage cancer patients. The product encompasses the proprietary microbiome signature for response prediction and the platform service provided to healthcare professionals to order the kit and analysis, and download the analysis report. The cloud-based nature of the software is able to store, transfer and analyse FASTQ files from next-generation-sequencing platforms and generate a PDF report containing the predicted response information. The diagnostic software performs bioinformatic workflows and infers response to checkpoint inhibitor based cancer immunotherapy using a proprietary signature based on statistical algorithms of microbiome samples from patients with non-small cell lung cancer, renal cell carcinoma and malignant melanoma.

How does BiomeOne work?

BiomeOne analysis uses microbial DNA, which is obtained from stool samples of cancer patients. The samples are collected by the patients themselves. CE-IVD labeled stool tubes from NorgenĀ® Biotek are used for temporary storage and transportation of the stool samples. In the laboratory, 50 – 1000 ng of a microbiome sample from a patient is subjected to 16S rRNA library construction. This is followed by amplicon sequencing with an average of 460 base pairs. Subsequently, clustering is carried out at species level.

A proprietary analysis pipeline assesses the raw data from DNA sequencing and enables the identification of cancer patients who are likely (Sensitivity > 80%) to benefit from a checkpoint inhibitor based cancer immunotherapy (CTLA-4, anti-PD-1 or anti-PD-L1). The mathematical models for calculating the clinical response are based on a random forest model. In addition, sequencing data are analyzed for irAEs of any grade during a checkpoint inhibitor as well as for specific signatures including bacterial constellations and parameters such as diversity and bacterial richness.

How can I order BiomeOne?

Place a test order online by logging in or signing-up for a BiomeDx Platform account. Complete the order form, including the address and provide any required details of the patient and submit.

How can I influence the microbiome?

A healthy diet that supports the gut microbiome can contribute to the success of cancer immunotherapy. It has been shown that patients with a balanced gut flora achieve significantly better response rates to immunotherapy than those with an unhealthy diet and disturbed gut flora. We support the patients by connecting them to the right dieticians. More information (in German) can be found here.