Periodic Reporting for period 1 - PCR-4-ALL (Impact and viability of a novel mass PCR testing method as a pandemic-fighting strategy)
Période du rapport: 2022-12-01 au 2024-05-31
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 main 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. PCR-4-ALL 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. A PCR-based testing strategy is chosen, since PCR (1) can be rapidly developed within a few days of obtaining the genetic map of a potential PX and (2) is sensitive and quantitative enough to translate results into a verifiable measure of infectivity potential. To achieve this, PCR-4-ALL will develop a completely new testing 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. PCR-4-ALL 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. A PCR-based testing strategy is chosen, since PCR (1) can be rapidly developed within a few days of obtaining the genetic map of a potential PX and (2) is sensitive and quantitative enough to translate results into a verifiable measure of infectivity potential. To achieve this, PCR-4-ALL will develop a completely new testing 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, developing economic model and epidemiological model are ongoing tasks. Related to AIM2, the first proof-of-concept saliva self-collection devices have been fabricated and tested with both artificial and real saliva samples. Furthermore, proof-of-concept experiments have demonstrated that a microfluidic, droplet-based digital system can be used to effectively screen a desired viral load while being compatible with a liquid handling robotic system. Moreover, a comprehensive strategy has been established for high-throughput digital-PCR screening in which appropriate reagents have been selected. Regarding AIM3, a digital cohort has been established for the project and different testing strategies have been performed to assess the distribution of acute respiratory infections in one season. The results can be communicated to participants via specially developed digital tool system and disseminated in real time on the dashboard, which is publicly accessible. Furthermore, several aspects of the PCR-4-ALL testing strategy implementation have been assessed through real-world COVID-19 case studies from Austria and China. Finally, an advisory board was established with whom preliminary discussions were held to support the PCR-4-ALL team in better refining its strategy and address potential challenges, to ensure the practical applicability of the project.
The impact of the PCR-4-ALL project is expected on 4 different levels:
- Scientific: (1) simple, inexpensive self-sampling method to be frequently applied to prevent spreading of infectious diseases and limiting the need for widespread containment measures and (2) ability to perform a wider range of population-based screens: e.g. for early cancer diagnosis.
- Societal: (1) prevent mortality and reduce years of life lost associated with the rapid PX appearance and (2) permit the normal functioning of societies (schools, public events, elderly homes).
- Economic: (1) build an evidence-based collection of knowledge on the nature and economic implications of rapid mass testing to avoid possible negative economic consequences from a rapidly arising health threat; (2) give insights for the implementation of standard settings for testing and screening strategies during the onset of a burden of disease with high rate of infection and (3) elucidate the economic benefits per person/society of increasing the rapidity and extent of tests (on the basis of the COVID-19 pandemic).
- Policy: provide policy recommendations on the actions to follow in case of an outbreak of an infectious disease in a certain areas.
With respect to delivering scientific impact, the work has been ongoing for developing an inexpensive and user-friendly saliva self-sampling tool as well as for establishing a massively parallelized sample processing and screening platform, with the latter expected to result in a patent application in the coming 12 months. In addition, to address the “ability to perform a wider range of population-based screens”, we have approached relevant researchers to discuss the further applicability of technologies developed in the PCR-4-ALL project for early cancer diagnosis with the aim to explore opportunities for new grant applications.
- Scientific: (1) simple, inexpensive self-sampling method to be frequently applied to prevent spreading of infectious diseases and limiting the need for widespread containment measures and (2) ability to perform a wider range of population-based screens: e.g. for early cancer diagnosis.
- Societal: (1) prevent mortality and reduce years of life lost associated with the rapid PX appearance and (2) permit the normal functioning of societies (schools, public events, elderly homes).
- Economic: (1) build an evidence-based collection of knowledge on the nature and economic implications of rapid mass testing to avoid possible negative economic consequences from a rapidly arising health threat; (2) give insights for the implementation of standard settings for testing and screening strategies during the onset of a burden of disease with high rate of infection and (3) elucidate the economic benefits per person/society of increasing the rapidity and extent of tests (on the basis of the COVID-19 pandemic).
- Policy: provide policy recommendations on the actions to follow in case of an outbreak of an infectious disease in a certain areas.
With respect to delivering scientific impact, the work has been ongoing for developing an inexpensive and user-friendly saliva self-sampling tool as well as for establishing a massively parallelized sample processing and screening platform, with the latter expected to result in a patent application in the coming 12 months. In addition, to address the “ability to perform a wider range of population-based screens”, we have approached relevant researchers to discuss the further applicability of technologies developed in the PCR-4-ALL project for early cancer diagnosis with the aim to explore opportunities for new grant applications.