Periodic Reporting for period 2 - ONELAB (Orchestrating next-generation mobile modular laboratories for pandemic monitoring preparedness)
Période du rapport: 2024-04-01 au 2025-09-30
World expert opinion (WHO) recommends “Rapid Response Mobile Laboratories” (RRML). ONELAB will develop modular RRML for rapid, flexible, scalable, multi-scenario deployments into the widest range of possible settings. These next-generation (NG) facilities will support measurement-technologies/methodologies (for a staged disease detection response) and, through satellite communications, laboratory information systems. Exploiting a panel of acute viral infection biomarkers enables early detection of disease during its asymptomatic incubation. Using this at the outbreak of disease supports effective immediate & targeted public health interventions. Using methodologies developed in response to COVID 19, ONELAB will develop & demonstrate a workflow for semi-autonomous disease-specific biomarker discovery and enhance the capability & capacity of current disease testing strategies.
ONELAB builds world-wide networks & partnerships of experts to define best practice; develop a concept of operation and disseminate this though a pandemic testing playbook and training & networking-events continuing beyond the project. A citizen’s guide to mass community testing (MCT) supported by educational outreach resources, will enhance engagement/acceptance from all citizens.
ONELAB builds world-wide networks & partnerships of experts to define best practice; develop a concept of operation and disseminate this though a pandemic testing playbook and training & networking-events continuing beyond the project. A citizen’s guide to mass community testing (MCT) supported by educational outreach resources, will enhance engagement/acceptance from all citizens.
We defined 8 specific and measurable objectives:
1. End-User direction assessment/evaluation of existing solutions; gaps; and lessons learnt from previous pandemics;
Lessons learnt are integrated in the CONOPS and consolidated in the ONELAB Guidance for Pandemic Testing Policies and the Pandemic Testing Playbook. End-user workshops in 6 countries assessed implementation of MCT and lessons learnt during the COVID-19 pandemic resulting in D2.4 P.E.L.S. analysis and was complemented with the citizen survey on awareness, acceptance and trust. The information was used to develop and evaluate the 2 Field Technical Exercises (FTX) and the readiness and capability assessment framework in D6.2.
2. NG RRML designed, developed & delivered to provide analytical quality by design in accordance with ICH 2 to meet wide range of monitoring mission goal.
The CONOPS provided a framework for the development of NGML. D5.1 describes detailed guidelines and workflows for both clinical studies and FTXs that ensure the implementation of analytical quality by design throughout the project development, validation and testing. ‘Lessons learned’-elements of D5.1 are again captured in D6.1 and D6.2.
3. Staged diagnostic capability and capacity for delivery of reliable and unambiguous detection and identification of infectious agents across all pandemic phases.
The CONOPS integrates current and future standards to take into account for the NGML Complementary diagnostic modalities; breath-based VOC profiling by GC-IMS and GC-MS, handheld sensor measurements, LC-MS assays were demonstrated. During the multi-centre clinical studies and in the FTX Pre-emptive exercise, outcomes consisting of blinded multi-site data, were integrated and analysed using AI/ML pipelines. Together with the 5-28-100 mobilisation premise and the Pandemic Testing Readiness scoring dashboard in D6.2 they provide a structured approach for scaling diagnostic capacity and capability across different pandemic phases.
4. ICT and data hub for field data communication & processing to facilitate decision-making by chain of command and authorities
The CONOPS provides a framework to support requirements for secure data flows, interoperability with public-health surveillance and the role of ICT. We developed an integrated ICT and data hub enabling secure multi-channel connectivity and structured storage, quality control and pre-processing of clinical and laboratory data and successfully deployed this during clinical studies and the FTX exercises.
5. Defining, classifying, and incorporating societal factors, constraints, and heuristics
The CONOPS explicitly addresses citizens’ trust and acceptance, policy objectives, ethical and legal principles and societal trade-offs in pandemic testing. In WP5&6, societal factors (inclusiveness, positive patient experience, non-intrusive sampling, accessibility, communication and trust) were incorporated in the definition of FTX scenarios, the Pandemic Testing Playbook and the ‘Assessment and capability framework’.
6. NG CONOPS for mobile pandemic monitoring operations.
D3.1 D2.4 D6.2.
7. Establish a worldwide pandemic community-testing forum
The online forum is operational and accessible via the website: https://onelab-project.eu/(s’ouvre dans une nouvelle fenêtre)
8. Promote international cooperation on pandemics with Japan, build scalable capacities for joint multinational intervention
The Japanese project partner made substantial contributions (integrated in D3.1) as one of the participating sites for the multicentre clinical studies and key sparring partners in the development of the FTX’s and RRML solution
1. End-User direction assessment/evaluation of existing solutions; gaps; and lessons learnt from previous pandemics;
Lessons learnt are integrated in the CONOPS and consolidated in the ONELAB Guidance for Pandemic Testing Policies and the Pandemic Testing Playbook. End-user workshops in 6 countries assessed implementation of MCT and lessons learnt during the COVID-19 pandemic resulting in D2.4 P.E.L.S. analysis and was complemented with the citizen survey on awareness, acceptance and trust. The information was used to develop and evaluate the 2 Field Technical Exercises (FTX) and the readiness and capability assessment framework in D6.2.
2. NG RRML designed, developed & delivered to provide analytical quality by design in accordance with ICH 2 to meet wide range of monitoring mission goal.
The CONOPS provided a framework for the development of NGML. D5.1 describes detailed guidelines and workflows for both clinical studies and FTXs that ensure the implementation of analytical quality by design throughout the project development, validation and testing. ‘Lessons learned’-elements of D5.1 are again captured in D6.1 and D6.2.
3. Staged diagnostic capability and capacity for delivery of reliable and unambiguous detection and identification of infectious agents across all pandemic phases.
The CONOPS integrates current and future standards to take into account for the NGML Complementary diagnostic modalities; breath-based VOC profiling by GC-IMS and GC-MS, handheld sensor measurements, LC-MS assays were demonstrated. During the multi-centre clinical studies and in the FTX Pre-emptive exercise, outcomes consisting of blinded multi-site data, were integrated and analysed using AI/ML pipelines. Together with the 5-28-100 mobilisation premise and the Pandemic Testing Readiness scoring dashboard in D6.2 they provide a structured approach for scaling diagnostic capacity and capability across different pandemic phases.
4. ICT and data hub for field data communication & processing to facilitate decision-making by chain of command and authorities
The CONOPS provides a framework to support requirements for secure data flows, interoperability with public-health surveillance and the role of ICT. We developed an integrated ICT and data hub enabling secure multi-channel connectivity and structured storage, quality control and pre-processing of clinical and laboratory data and successfully deployed this during clinical studies and the FTX exercises.
5. Defining, classifying, and incorporating societal factors, constraints, and heuristics
The CONOPS explicitly addresses citizens’ trust and acceptance, policy objectives, ethical and legal principles and societal trade-offs in pandemic testing. In WP5&6, societal factors (inclusiveness, positive patient experience, non-intrusive sampling, accessibility, communication and trust) were incorporated in the definition of FTX scenarios, the Pandemic Testing Playbook and the ‘Assessment and capability framework’.
6. NG CONOPS for mobile pandemic monitoring operations.
D3.1 D2.4 D6.2.
7. Establish a worldwide pandemic community-testing forum
The online forum is operational and accessible via the website: https://onelab-project.eu/(s’ouvre dans une nouvelle fenêtre)
8. Promote international cooperation on pandemics with Japan, build scalable capacities for joint multinational intervention
The Japanese project partner made substantial contributions (integrated in D3.1) as one of the participating sites for the multicentre clinical studies and key sparring partners in the development of the FTX’s and RRML solution
12 Key Exploitable Results (KER) were identified, spanning technologies (devices, RRML, LIMS), data and ICT, concepts of operation, policy and governance tools and training assets. These are a mix of technical innovations and policy recommendations. During a HORIZON Booster workshop these results were analysed as it concerns strategies for valorisation.
4 KERs were prioritised for in-depth business planning:
• KER1 (RRML): A modular, deployable mobile laboratory concept and prototype, demonstrated during FTXs Hard Winter and suitable for further development, industrialisation and regulatory alignment.
• KER2 (LIMS): A pandemic-ready LIMS and ICT module for RRML and decentralised testing, at TRL ~5, with clear licensing-based exploitation intentions.
• KER3 (ONELAB Solution): An integrated package combining RRML, LIMS, CONOPS, playbook, capability/assessment, QA and training; a potential turnkey solution for national and international pandemic testing preparedness.
• KER4 (Consultancy): A structured consultancy and capacity-building offer for public authorities, leveraging ONELAB’s policy guidance, P.E.L.S. analysis, legal/ethical frameworks and citizen trust evidence.
Across these KERs, ONELAB has moved from concept to demonstrator/trial stage, created clear value propositions and preliminary exploitation models and generated a rich policy and governance toolkit. The main needs for further uptake are: scaled real-world demonstrations; industrialisation and certification; access to markets and finance (especially for public buyers); robust IPR and licensing arrangements; and alignment with international regulatory and standardisation frameworks, notably WHO GOARN RRML/DiSC and relevant EU standards.
4 KERs were prioritised for in-depth business planning:
• KER1 (RRML): A modular, deployable mobile laboratory concept and prototype, demonstrated during FTXs Hard Winter and suitable for further development, industrialisation and regulatory alignment.
• KER2 (LIMS): A pandemic-ready LIMS and ICT module for RRML and decentralised testing, at TRL ~5, with clear licensing-based exploitation intentions.
• KER3 (ONELAB Solution): An integrated package combining RRML, LIMS, CONOPS, playbook, capability/assessment, QA and training; a potential turnkey solution for national and international pandemic testing preparedness.
• KER4 (Consultancy): A structured consultancy and capacity-building offer for public authorities, leveraging ONELAB’s policy guidance, P.E.L.S. analysis, legal/ethical frameworks and citizen trust evidence.
Across these KERs, ONELAB has moved from concept to demonstrator/trial stage, created clear value propositions and preliminary exploitation models and generated a rich policy and governance toolkit. The main needs for further uptake are: scaled real-world demonstrations; industrialisation and certification; access to markets and finance (especially for public buyers); robust IPR and licensing arrangements; and alignment with international regulatory and standardisation frameworks, notably WHO GOARN RRML/DiSC and relevant EU standards.