Research use
Research use only. Not a medical device.
This software was developed in the HEREDITARY project as a research prototype. It has not been assessed or certified under the EU Medical Device Regulation (EU) 2017/745. It must not be used to diagnose, treat, monitor, or make any other decision about individual patients.
Intended use
mllabiome supports research analyses of processed microbiome feature or abundance data, including predictive modelling, model comparison, cross-cohort evaluation, multimodal integration, explainability, robustness analysis, and exploratory hypothesis generation.
Intended users are biomedical researchers, microbiome researchers, bioinformaticians, computational biologists, biostatisticians, machine-learning researchers, and data scientists with appropriate expertise.
Out of scope
The software must not be used for clinical diagnosis, prognosis, treatment, monitoring, or other clinical management of individual patients; decisions about individuals such as insurance, employment, or access to care; or re-identification of research participants.
Predictive feature importance and explainability outputs must not be interpreted as proof of causal biological effects.
The optional interactive interface is a research demo. Do not enter personal or patient data.
Data responsibility
The software release itself should contain no personal data, pseudonymized research-participant records, identifiers, or pseudonymization keys. Users remain responsible for the lawful and ethical processing of any datasets they supply to the software.
Limitations
Performance depends on population, cohort, sample collection, sequencing or profiling technology, upstream bioinformatics, phenotype definition, class balance, modelling choices, and validation design. Performance from one dataset or cohort must not be assumed to generalize to another setting without independent validation.
Funding acknowledgement
Funded by the European Union under grant agreement No 101137074 (HEREDITARY). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HaDEA). Neither the European Union nor the granting authority can be held responsible for them.
The software is released under the Apache License 2.0. See the repository LICENSE file for license terms.