Periodic Reporting for period 2 - PCR-4-ALL (Impact and viability of a novel mass PCR testing method as a pandemic-fighting strategy)
Periodo di rendicontazione: 2024-06-01 al 2025-11-30
To strengthen our preparedness for future pandemics arising from a yet unknown pandemic-causing Pathogen X (PX), there is a need to develop more advanced interventions that can be deployed as soon as such PX is discovered and that can reconcile economic activity with public safety. To achieve this vision PCR-4-ALL project is tackling three aims:
AIM1 - set the basis for (1) a thorough understanding of the potential epidemiologic efficacy of mass testing in the context of an arising pandemic and (2) a critical assessment of the requirements needed to make such strategy economically viable. We will do this by developing epidemiologic models based on the characteristics of currently known pandemic-causing pathogens (i.e. SARS-CoV-2, H1N1) and by establishing economic models that capture the impact from the most relevant measures implemented to fight the COVID-19 in the countries of the participating partners at both societal and the economic levels.
AIM2 - demonstrate that “mass testing for infectivity” is technically feasible. By selecting a PCR-based testing strategy, we will develop a completely new strategy including:
- an advanced sample collection method to allow upscaling of testing at low cost. This can only be done via a sampling method that: (1) is easy to apply and widely accepted by all segments of the population; (2) requires a minimum of sample, reagents and little (or no) sample preparation; and (3) can be seamlessly integrated within lab automation platforms (to enable upscaling).
- a method enabling massively parallelized testing with minimum amounts of reagents and samples. To address this, PCR-4-ALL will develop specialized microfluidic technology and associated liquid handling robotic technologies for ultrafast identification of PCR results in a digital manner.
- a set of fit-for-purpose RT-qPCR reagents compatible with the previous sampling and testing strategies, ensuring that reagents can be obtained at the most affordable costs while guaranteeing their supply chain security.
AIM3 - determine the generic requirements needed to deploy the above described technologies so that they can be used effectively in the context of any future pandemic caused by an airborne PX. PCR-4-ALL will do this in consultation with a panel of experts and through a diversity of activities, including: pilot assessments, logistics analysis, manufacturability assessment, legal and authorization landscape, digital tools, cost of implementation and the completion of a strategic utilization plan.
The PCR-4-ALL project directly responds to HORIZON-HLTH-2022-DISEASE-07 and delivers pathways to directly impact society during pandemics in the following aspects: (1) better understanding of pathogen transmission; (2) developing new prevention measures, public health interventions and diagnostics; (3) establishing better methodologies to allow timely and accurate diagnostics; (4) better preparedness to manage epidemic outbreaks to reduce the disease burden on patients through empowerment of the EU to respond quickly and efficiently to health emergencies; (5) better surveillance of health threats and pandemics; (6) tailored EU policies and legal frameworks and at global level; (7) potential synergies with projects funded under Horizon Europe; and (8) ‘Creating a more resilient, inclusive and democratic European society’.
AIM1 - set the basis for (1) a thorough understanding of the potential epidemiologic efficacy of mass testing in the context of an arising pandemic and (2) a critical assessment of the requirements needed to make such strategy economically viable. We will do this by developing epidemiologic models based on the characteristics of currently known pandemic-causing pathogens (i.e. SARS-CoV-2, H1N1) and by establishing economic models that capture the impact from the most relevant measures implemented to fight the COVID-19 in the countries of the participating partners at both societal and the economic levels.
AIM2 - demonstrate that “mass testing for infectivity” is technically feasible. By selecting a PCR-based testing strategy, we will develop a completely new strategy including:
- an advanced sample collection method to allow upscaling of testing at low cost. This can only be done via a sampling method that: (1) is easy to apply and widely accepted by all segments of the population; (2) requires a minimum of sample, reagents and little (or no) sample preparation; and (3) can be seamlessly integrated within lab automation platforms (to enable upscaling).
- a method enabling massively parallelized testing with minimum amounts of reagents and samples. To address this, PCR-4-ALL will develop specialized microfluidic technology and associated liquid handling robotic technologies for ultrafast identification of PCR results in a digital manner.
- a set of fit-for-purpose RT-qPCR reagents compatible with the previous sampling and testing strategies, ensuring that reagents can be obtained at the most affordable costs while guaranteeing their supply chain security.
AIM3 - determine the generic requirements needed to deploy the above described technologies so that they can be used effectively in the context of any future pandemic caused by an airborne PX. PCR-4-ALL will do this in consultation with a panel of experts and through a diversity of activities, including: pilot assessments, logistics analysis, manufacturability assessment, legal and authorization landscape, digital tools, cost of implementation and the completion of a strategic utilization plan.
The PCR-4-ALL project directly responds to HORIZON-HLTH-2022-DISEASE-07 and delivers pathways to directly impact society during pandemics in the following aspects: (1) better understanding of pathogen transmission; (2) developing new prevention measures, public health interventions and diagnostics; (3) establishing better methodologies to allow timely and accurate diagnostics; (4) better preparedness to manage epidemic outbreaks to reduce the disease burden on patients through empowerment of the EU to respond quickly and efficiently to health emergencies; (5) better surveillance of health threats and pandemics; (6) tailored EU policies and legal frameworks and at global level; (7) potential synergies with projects funded under Horizon Europe; and (8) ‘Creating a more resilient, inclusive and democratic European society’.
With respect to AIM1, we developed and applied a disease-spread model to compare how well different testing strategies (including large-scale testing) could detect and control a pandemic. Combining with epidemiological outputs, such as infections, hospitalizations, and deaths avoided, we also developed a decision-analytic economic model with direct and indirect cost estimates, allowing for the calculation of Incremental Cost-Effectiveness Ratios (ICERs) across alternative testing and intervention strategies for assessing cost-effectiveness. Related to AIM2, we further advanced our user-friendly saliva sample collector by improving its design and made it compatible with downstream automated laboratory equipment, followed by both technical and analytical validations. Moreover, we have developed a strategy to combine thousands of samples by transforming them into microscopic droplets and processing them together with automated laboratory equipment. Also, we have assessed that our test will be effective in detecting the latest SARS-CoV-2 variants, as well as Influenza A subtypes of public health relevance, next to optimizing the conditions to ensure reliable virus detection in saliva samples collected in sampling cards. Regarding AIM3, we set up and ran a digital cohort study over two seasons to assess which self-testing and sampling approaches best identify acute respiratory infections and how user-friendly the used digital tool is. Moreover, we identified the key requirements for large-scale testing during future pandemics, including how to collect and transport samples efficiently, how to integrate them into automated labs, and how to ensure the whole process is fast, reliable, and ready to scale when needed.
The impact of the PCR-4-ALL project is expected on 4 different levels:
- Scientific: the project is advancing several innovative technologies and methodologies that will transform diagnostic testing and screening, including self-sampling tool, platform for massively parallel droplet generation enabling high-throughput PCR tests, customized PCR reagents, next to epidemiological and economic models.
- Societal: the project provides a scalable platform for early disease detection and continuous population monitoring through simple, low-cost self-sampling and digital reporting. The platform enables early identification of infectious individuals, frequent monitoring of population infectivity, and expanded applications such as cancer biomarker screening, HIV self-testing, therapeutic drug monitoring, and high-throughput pharmaceutical assays.
- Economic: PCR-4-ALL project integrates combined epidemiologic and economic models to estimate the impacts of advanced interventions. Additionally, the platform supports cost-benefit analyses for smaller groups, and demonstrates measurable savings from rapid testing for potential future pathogen scenarios. PCR-4-ALL provides evidence for investment in testing infrastructure, reducing healthcare costs and productivity losses.
- Policy: PCR-4-ALL supports the identification of actions required during pandemic outbreaks and enables the development of rapid response strategies to contain disease spread effectively. These outcomes inform policy recommendations for outbreak response that are tailored to specific transmission modes and epidemic phases. They also facilitate the harmonization of testing protocols across EU member states, ensuring a coordinated and efficient pandemic management.
- Scientific: the project is advancing several innovative technologies and methodologies that will transform diagnostic testing and screening, including self-sampling tool, platform for massively parallel droplet generation enabling high-throughput PCR tests, customized PCR reagents, next to epidemiological and economic models.
- Societal: the project provides a scalable platform for early disease detection and continuous population monitoring through simple, low-cost self-sampling and digital reporting. The platform enables early identification of infectious individuals, frequent monitoring of population infectivity, and expanded applications such as cancer biomarker screening, HIV self-testing, therapeutic drug monitoring, and high-throughput pharmaceutical assays.
- Economic: PCR-4-ALL project integrates combined epidemiologic and economic models to estimate the impacts of advanced interventions. Additionally, the platform supports cost-benefit analyses for smaller groups, and demonstrates measurable savings from rapid testing for potential future pathogen scenarios. PCR-4-ALL provides evidence for investment in testing infrastructure, reducing healthcare costs and productivity losses.
- Policy: PCR-4-ALL supports the identification of actions required during pandemic outbreaks and enables the development of rapid response strategies to contain disease spread effectively. These outcomes inform policy recommendations for outbreak response that are tailored to specific transmission modes and epidemic phases. They also facilitate the harmonization of testing protocols across EU member states, ensuring a coordinated and efficient pandemic management.