AI-supported metagenomic diagnostics for personalised medicine
GenDAI was conceived as an integrated medical-diagnostics platform that connects consented microbiome samples, automated metagenomic processing, secure cloud infrastructure, AI-based biomarker discovery and interactive clinical reporting. Its purpose is to accelerate the conversion of research and technology into personalised diagnostic services while respecting laboratory and regulatory requirements.
Microbiome research can generate valuable evidence, but clinical translation requires more than an accurate model. Samples, metadata, processing pipelines, biomarkers, access controls, visual reporting, validation and regulatory evidence must operate as one traceable diagnostic system.
Research questions
The questions connect the real-world problem with research activities and evaluable contributions.
How can consented microbiome samples be converted into reproducible and clinically meaningful data?
How can non-automated work in the diagnostic pipeline be reduced without weakening quality control?
Which secure data and knowledge infrastructure supports reproducibility and long-term archiving?
How can AI identify biomarkers and classify metagenomic sequences with measurable improvement?
How should results be visualised so clinicians can interpret them efficiently and safely?
Which evidence is required to move the technology toward IVDR-compliant use?
The research-project architecture
The GenDAI architecture connects clinical inputs, metagenomic processing, secure data services, AI-supported discovery, reporting and validation as one diagnostic pathway.
Piloting, validation and measurable improvementDataset growth · Automation time · Software security · AI accuracy · Reporting performance · Cognitive workload · Compliance
Figure: GenDAI integrated research and innovation architecture, connecting the six project objectives across the clinical, data, AI and regulatory pathway.
The architecture begins with patients, informed consent, clinical requirements and microbiome samples. The automated diagnostics workflow converts raw metagenomic material into quality-controlled and traceable data products. These products enter the integrated GenDAI platform, where GenDAI Safe governs cloud data, security, reproducibility and archiving; GenDAI Discovery uses AI to identify biomarkers and classify sequences; and Interactive Reporting turns analytical outputs into interpretable clinical views. Piloting and validation measure performance across the complete chain. Regulatory evidence, ethics and quality management therefore surround the architecture rather than appearing only at the end. The intended result is a validated diagnostic capability that supports personalised assessment and monitoring.
Research and Innovation Objectives
Table 1 translates the proposed platform into six measurable objectives. The mid-term and final targets make progress reviewable across clinical data, automation, infrastructure, AI performance, reporting and regulation.
Objective
Platform result
Purpose
Selected KPI
M18
M36
RIO 1
Clinical dataset
Consented IBD patient microbiome samples
Patients / samples
100
2,000
RIO 2
Diagnostics workflow
Fully automated metagenomic processing
Manual minutes per sample
10
5
RIO 3
GenDAI Safe
Secure, reproducible cloud data and knowledge infrastructure
OpenSSF scorecard
7.5/10
8.5/10
RIO 4
GenDAI Discovery
AI biomarker discovery and metagenomic classification
Fine-tuned classification accuracy
75%
85%
RIO 5
Interactive Reporting
Visual analysis and clinical reporting
Processing time / error rate
180 s / 5%
30 s / 1%
RIO 6
Clinical translation
Marketable and regulatory-compliant tool suite
IVDR compliance
—
100%
Table 1: Selected GenDAI Research and Innovation Objectives and milestone targets.
The objectives deliberately combine different kinds of evidence. RIO 1 measures whether the clinical dataset reaches sufficient scale. RIO 2 tests whether the workflow reduces manual processing. RIO 3 evaluates software and access-policy quality, while RIO 4 measures the improvement of AI classification. RIO 5 examines speed, failure rate and the clinician’s cognitive workload. RIO 6 brings the strands together by requiring the integrated technology to produce the evidence needed for regulatory-compliant operation.
CONSORTIUM CONTRIBUTION
Philippe Tamla’s participation
Prof. Philippe Tamla contributed to the GenDAI consortium through January 2026. The interdisciplinary work connected clinical requirements, metagenomic processing, cloud and data infrastructure, artificial intelligence, interactive reporting, integration and validation within one research and innovation programme.
His experience includes connecting research objectives, work packages, system architecture and measurable indicators while considering the transition from research outputs to usable, regulated technology. GenDAI’s results remain the collective work of the consortium.
Research workstreams
Each workstream addresses a distinct part of the project while remaining connected to the shared architecture and questions.
Clinical data foundation
Create consented metagenomic datasets from patients with inflammatory bowel disease and preserve the clinical and ethical context of every sample.
Diagnostics workflow
Integrate a largely automated data-processing pipeline that reduces manual effort while keeping sample and quality controls explicit.
GenDAI Safe
Provide secure cloud-based data and knowledge infrastructure for reproducibility, controlled access and long-term archiving.
GenDAI Discovery
Develop AI methods for biomarker identification, sequence classification and personalised microbiome profiling.
Interactive Reporting
Translate analytical results into visual clinical reports that reduce processing time, errors and cognitive workload.
Piloting and regulation
Validate the integrated system and assemble evidence needed for marketability and compliance with the In Vitro Diagnostic Regulation.
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