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KU Leuven-led Project Aims to Develop Mass PCR Testing Platform for Future Pandemics

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NEW YORK – A new, EU-backed research project aims to develop a technology platform that could support population-wide PCR testing, providing public health authorities with a tool that could potentially lessen the impact of future pandemics on national healthcare systems and economies.

The project, called PCR-4-All, officially commenced Dec. 1 and will run through November 2026. Its kickoff meeting will be held in January. PCR-4-All has a budget of €3.4 million ($3.6 million). Catholic University Leuven in Belgium is leading PCR-4-All. Other participating institutions include the Helmholtz Center for Infection Research in Braunschweig, Germany; the University of Verona in Italy; and the IrsiCaixa AIDS Research Institute in Barcelona, Spain, which focuses on emerging infectious diseases.

Xevi Casadevall i Solvas, an assistant professor at KU Leuven, is the principal investigator of PCR-4-All. Casadevall i Solvas specializes in developing high-throughput screening assays using microfluidic and lab-on-chip technologies. A recent publication describes the development of a droplet microfluidic approach for the screening and sorting of antibody-secreting cells using a Förster resonance electron transfer (FRET)-based assay, for example.

According to Casadevall i Solvas, the COVID-19 pandemic inspired him to consider using some of his high-throughput screening approaches to support scalable PCR testing. He noted in an interview that while other tools for managing the pandemic became available later on — such as vaccines or lateral flow tests — PCR emerged within a matter of weeks as the routine testing tool.

He also cited the experience of Luxembourg, which because of its size — its current population is about 640,000 people — was able to implement a large-scale testing strategy. At the peak of the pandemic, Luxembourg was testing 20,000 people per day for SARS-CoV-2. "This helped them stay open for a much longer time than many other economies," commented Casadevall i Solvas.

By combining miniaturized, high-throughput screening technologies with PCR, Casadevall i Solvas believes that the PCR-4-All Consortium can develop a scalable approach that could support the testing of perhaps 100,000 people per day or even more. "One hundred thousand is ambitious, but we could do more," he added. "It's not conservative but not the limit."

Casadevall i Solvas declined to describe the proposed technology in detail but said that it has not been published yet as part of any previous work and that it is not yet protected by IP. It involves miniaturization and lab-on-chip technologies.

Among PCR-based platforms, Roche's Cobas 6800 and 8800 systems have been widely used for SARS-CoV-2 testing, for example. The systems provide up to 96 results in about three hours and a total of 384 results for the 6800 system and 1,056 results for the 8800 system in eight hours, according to the company.

"Governments had to finance and pump money into clinical diagnostic laboratories to buy PCR machines, one after the other," remarked Casadevall i Solvas. "But we believe we can parallelize at a large scale many of the steps involved in PCR that are otherwise constrained by using one instrument," he added. "That is key in the project."

Further discussing the technology, Casadevall i Solvas described plans for a sample acquisition system that will be inexpensive and capable of isolating nucleic acids from a large number of samples. This will be aligned with a means of running the PCR reactions at scale. The participating investigators will also look at ways of cutting down on reagents while developing strategies to ensure accuracy. "We will miniaturize everything and use less reagents," he said. Armed with such a platform, authorities would be able to support a large-scale testing strategy.

The other partners participating in PCR-4-All have different areas of expertise. Casadevall i Solvas said that the investigators from the University of Verona are versed in developing theoretical economic models for use in economic policymaking and the study of public health economics. The German partner, the Helmholtz Center for Infection Research, specializes in modeling infectious diseases as well as in developing digital health platforms. They also have a cohort of volunteers for surveillance studies. The IrsiCaixa AIDS Research Institute has experience with using PCR technology for identification and characterization of infectious agents that will inform its contribution to PCR-4-All.

The end goal is not to have a ready-made tool or product per se but to establish proof of principle. "We want to show that our platform could deliver testing at this rate," said Casadevall i Solvas. The consortium will also produce data around how massive screening could reduce disease burden in terms of hospitalizations and deaths and also keep economies open in the case of another pandemic, along with a cost-benefit analysis of using the screening platform as part of a testing strategy.

"Then we can potentially propose this as a pandemic management platform," said Casadevall i Solvas. He suggested that the European Health Emergency Preparedness and Response Authority (HERA), a new EU body established in September 2021, could be an ideal target for such a "white book" of data on this high-throughput PCR platform.

HERA's duties include carrying out threat assessments, intelligence gathering, and developing models to forecast outbreaks. It is also charged with supporting medical countermeasures, such as scaling manufacturing of tests and vaccines and addressing supply chain bottlenecks.

Making such a high-throughput PCR testing platform available could save lives and help keep economies open, Casadevall i Solvas stressed.

"A third of the people who died in the COVID-19 pandemic died in the first year," he said. "When these things hit, they hit fast. It's important to be able to act fast at the beginning."

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