1-Optimization of blood culture for human blood and synovial fluid as exemplary specimen types (WP2): DRAIGON advanced a standardized, automated workflow for rapid pathogen detection and genomic AST in blood and synovial fluid using long-read sequencing. Key steps included optimizing DNA extraction, host depletion, and integrating a stable ONT premix into the DRAIGONPrep microfluidic platform. This seamless workflow addresses urgent diagnostic needs and supports scalable adoption in clinical and public health settings.
2-Application of cloud-based analysis software using AI models for antibiotic susceptibility prediction (genomic AST; gAST)AMR marker detection and genomic surveillance (WP3/4/5/6): DRAIGON enhanced AI-powered tools for genomic profiling of bloodstream and joint infections by expanding the DraGNOME model for MIC prediction using long-read sequencing. Key work included refining pipelines, curating AMR/virulence databases, and training on 100,000+ genomes and >1000 in-house sequenced MDR strains. A unified cloud-based reporting tool was developed to support rapid, accurate diagnostics and AMR prediction, with potential impact in both high- and low-resource settings.
3-Clinical utility studies addressing blood stream infections (BSI) and prosthetic joint infections (PJI) (WP4/5/7) will be performed in two tertiary care institutions in the EU (Isala and OSS) and two university hospitals, one in the EU (UMCG) and one in the US (JHU), respectively: We advanced clinical validation of genomic pathogen profiling and rapid gAST in bloodstream and joint infections via multi-site studies (Isala, OSS, UMCG, JHU). DNA extraction protocols were optimized, and workflows tested on clinical samples within 24 hours of positivity. Proof-of-concept trials and meta-analyses support assessing diagnostic accuracy and patient impact, informing health-economic models and implementation in diverse healthcare settings.
4-Capacity-building and proof-of-concept study in a medium-resource environment (WP6).UHSN will use DRAIGONPrep and DraGNOME to carefully collect and analyze patient samples. The focus will be on detecting both common infections and those caused by bacteria that are resistant to multiple antibiotics. This will help us test how well the DraGNOME system works, including its cloud-based reporting tools. The goal is to gather strong evidence to show how the system can help doctors choose better antibiotics, fit smoothly into hospital routines, and improve patient care. This will benefit both hospitals with lots of resources and those with fewer resources. As part of this effort, we will also improve the labs’ capabilities by providing training and new equipment.
5-Development of automated liquid handling and sequencing scales for near point of care (WP2): After assessing several technologies, Camtech chose digital microfluidics (electrowetting-on-dielectric, EWOD) for its automated liquid handling prototype, developing a benchtop system and palm-sized microfluidic chips from conductive glass and plastic to perform DNA extraction and library preparation, incorporating clinical partners feedback; full performance testing is still ongoing.
6-Regulatory plan for IVDR acceptance(WP8): To get the device approved for the EU market under IVDR, we first define its purpose and risk category, and gap analysis. A quality system following ISO 13485 is ongoing and prepare all the necessary documents and test results. We also establish strong procedures for DraGNOME to monitor the device’s safety after launch, protect patient data under GDPR, ensure cybersecurity, and adjust for any national requirements. Throughout, we continuously track regulatory changes and assign clear roles and deadlines to secure CE marking and keep the device available and safe for patients.
