DRAIGON holds review meeting with European Commission, partners reflect on progress and next phase
- European Vaccine Initiative
- 11 minutes ago
- 2 min read
On October 1st, 2025, the DRAIGON consortium held its first review meeting with the European Commission (EC), a panel of external scientific experts and project partners, in hybrid format. More than 15 participants joined, representing all beneficiaries, affiliated partners, the EC project officers, and three external reviewers. This milestone marked the formal assessment of the first 18 months of progress set the direction for the next phase.
During the first 18 months, the project made strong progress across all work areas. Standard operating procedures were established, extraction kits benchmarked, and DRAIGONPrep prototypes delivered to sites. An initial version of the data analysis and reporting software was developed and is currently undergoing testing, alongside updates to the database and cloud infrastructure.
Preparations for clinical utility studies were completed, proof-of-concept sequencing began, and early Health Technology Assessment was finalized. The IVDR roadmap and quality management system planning also started, ensuring alignment with data protection, cybersecurity, and AI regulations.
Work package leads detailed where deviations from original plans had occurred, what mitigation strategies have been adopted, and how contingency plans will be implemented in the next phases. Key risks include limited access to microbial datasets, sequencing throughput issues, and potential regulatory delays. To address these, alternative datasets are being sourced, multiplexing limits adjusted, and vendor collaboration strengthened to improve flow-cell stability. Automation challenges are managed through iterative testing and dual-site validation, while the regulatory and ethical aspects advance in parallel through early consultations and harmonized SOPs. These measures aim to maintain performance, compliance, and continuity across all sites.
All partners expressed renewed commitment and enthusiasm to deliver on the project’s ambitious goals.
The next phase focuses on stabilizing sequencing performance, standardizing protocols, and validating DRAIGONPrep at clinical sites. Further development will strengthen data infrastructure, expand the genotypic antimicrobial susceptibility testing to reach ≥90% analytical performance, and broaden species–antibiotic coverage. The team will finalize the full HTA, implement the quality management system, and hold a stakeholder meeting in October 2025.
Capacity building, sustainability planning, and expansion of prospective clinical studies will support long-term adoption beyond the project’s lifetime.
We thank the European Commission, the review panel, and all DRAIGON partners for their constructive input, collaborative spirit, and dedication. This review meeting served as a valuable checkpoint and momentum booster as we move firmly into the next project phase.
PROJECT COORDINATOR
CONTACT
Adriana Vives
European Vaccine Initiative (EVI) - Project Manager
Email: adriana.vives@euvaccine.eu
PROJECT COORDINATOR
The European Vaccine Initiative (EVI) (Germany)