BiomeOne® was developed by the company Biome Diagnostics GmbH. Biome Diagnostics GmbH is double ISO-certified (ISO 9001:2015 and ISO 13485:2016).
BiomeOne® with the parameter "clinical response" fulfills the requirements of the European Directive 98/79 EC for in vitro diagnostic medical devices and is registered as a CE-IVD product by Biome Diagnostics GmbH, Rivergate, Handelskai 92, Gate 2/1.OG/B+G, 1200 Vienna, Austria. The parameter "Tolerability" is Research-Use-Only (RUO).
The parameters diversity, bacterial species richness and enterotype are scientifically established and serve to improve the overall assessment of a patient's gut microbiome.
The entire analysis can be used for both clinical and scientific purposes.
Intended use
BiomeOne® is a cloud-based in vitro diagnostic software for detecting responders and non-responders to cancer immunotherapy with checkpoint inhibitors (CTLA-4, PD-1, PD-L1) based on stool microbiome profiles of late-stage cancer patients. The product includes the proprietary microbiome signature for response prediction and the platform for healthcare professionals to order the kit and analysis and download the analysis report. The cloud-based software is able to store, transfer and analyze FASTQ files from next-generation sequencing platforms and generate a PDF report with the probability of response. The diagnostic software performs bioinformatic workflows and determines response to immunotherapy with checkpoint inhibitors using a proprietary microbiome signature based on statistical algorithms of microbiome samples from patients with non-small cell lung cancer, renal cell carcinoma and malignant melanoma.
The results described in the BiomeOne® report serve as additional information for the attending physician and should not be used as the sole basis for or against a therapy with checkpoint inhibitors. BiomeOne® may only be used by qualified healthcare professionals. The analysis provides clinically relevant and reproducible quantitative data to improve therapy management.
The primary performance study was conducted in the following three tumor types: non-small cell lung cancer, renal cell carcinoma and malignant melanoma. Female and male participants were equally included in the study. BiomeOne® is indicated for use in in vitro diagnostics with a response prediction sensitivity of > 80 %.
Indications
BiomeOne® was developed for use in stage III and stage IV cancer patients and validated in the following indications: non-small cell lung cancer, renal cell carcinoma and malignant melanoma. The analysis can be used in patients aged between 18 and 90 years.
Diagnostic significance
BiomeOne® identifies patients who benefit (responders) or do not benefit (non-responders) from immunotherapy with checkpoint inhibitors (CTLA-4, anti-PD-1 or anti-PD-L1).
Responders are defined as patients with complete remission (CR) or partial remission (PR). Non-responders are defined as patients with stable disease or progression (PD).
Laboratory analysis
Only microbial DNA obtained from stool samples of cancer patients is used for the BiomeOne® analysis. The samples are collected by the patients themselves. CE-IVD marked stool tubes from Norgen® Biotek are used for temporary storage and transportation of the stool samples. In the laboratory, 50 - 1000 ng of a patient's stool sample is subjected to 16S rRNA library construction. This is followed by amplicon sequencing with an average of 460 base pairs. This is followed by clustering at the species level.
Using the Illumina MiSeq® platform, the libraries are sequenced with high uniform depth (> 50,000 paired-end reads).
Bioinformatic analysis
A proprietary analysis pipeline evaluates the raw data obtained from DNA sequencing and enables the identification of cancer patients who may benefit from immunotherapy with checkpoint inhibitors (CTLA-4, anti-PD-1 or anti-PD-L1) (sensitivity > 80%). The mathematical models used to calculate the clinical response are based on a random forest model. In addition, the sequencing data is analyzed for irAEs of all grades and specific signatures including bacterial constellations and parameters such as diversity and species richness are calculated.
Limitations
It is recommended to wait at least 30 days after the last administration of systemic antibiotics before taking a stool sample for analysis. The adverse effects of antibiotics on the gut microbiome can significantly affect the test results.
Legal disclaimer
Biome Diagnostics makes no promises or guarantees that a patient will or will not respond to any particular treatment. In addition, Biome Diagnostics makes no promises or guarantees regarding the possible occurrence or non-occurrence of immune-related adverse events.
Biome Diagnostics makes no promises or guarantees that any healthcare provider, insurance company or other payor, private or governmental, will reimburse a patient for the cost of BiomeOne.
The information in this report must be considered with all other relevant information about the patient before any treatment decision is made. Decisions about patient care and treatment must be based on the independent medical judgment of the treating physician.
