Development of a global diagnostic ecosystem for detecting and monitoring emergency-prone pathogens across species and in a unified way

Informazioni relative al progetto

UniHealth

ID dell’accordo di sovvenzione: 101137092

DOI

10.3030/101137092

Data della firma CE 8 Dicembre 2023

Data di avvio 1 Dicembre 2023

Data di completamento 31 Maggio 2027

Finanziato da

• Health

Costo totale

€ 5 345 960,00

Contributo UE

€ 4 887 345,13

Coordinato da

IDRYMA TECHNOLOGIAS KAI EREVNAS
Greece

Periodic Reporting for period 1 - UniHealth (Development of a global diagnostic ecosystem for detecting and monitoring emergency-prone pathogens across species and in a unified way)

Periodo di rendicontazione: 2023-12-01 al 2025-05-31

Sintesi del contesto e degli obiettivi generali del progetto

The COVID-19 pandemic exposed critical weaknesses in global health systems, particularly in the ability to diagnose and respond quickly to emerging infectious diseases. These vulnerabilities highlighted the urgent need for accessible, affordable and accurate diagnostic tools that can be used not only in hospitals and clinics, but also in remote or resource-limited settings.

The UniHealth project responds directly to this need by developing a next-generation diagnostic ecosystem that enables the rapid detection and monitoring of infectious diseases with pandemic potential. The project aims to create universal, point-of-care diagnostic tools capable of detecting a broad range of viruses—including coronaviruses, influenza viruses and arboviruses such as Zika, Dengue and West Nile virus—in humans, animals and environmental samples. This cross-species detection capability aligns with the “One Health” approach, which recognizes the interconnected health of people, animals, and ecosystems.

UniHealth brings together academic, clinical, industrial and non-profit partners across Europe and Africa. Over a three-year and a half period, this multidisciplinary team will develop innovative molecular assays and two portable diagnostic devices. These tools will be easy to use, cost-effective and compatible with different sample types, such as blood, saliva, urine or mosquito extracts. The project also includes strategies for rapid deployment during health emergencies, regulatory clearance and engagement with end users and citizens to ensure the technologies are widely accepted and practically implemented.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

During the first 18 months of the project, we worked towards the achievement of all goals described in the original proposal for the set period. In WP1 (BIOPIX), the next generation of the improved PEBBLE device was produced, together with an industrial grade-manufactured pocket size device (Pixl). Regarding WP2 (FORTH), we selected the genomic regions and worked on the primers design for the following targets: SARS-CoV-2, MERS, West Nile, Zika and Dengue using an in-house developed pipeline tool; we also finalized the Universal primer mix for three samples (swab, urine, saliva) while one is on-going (plasma) and demonstrated the performance of three optimized assays (pan-Corona, Zika and avian influenza) in the lab, while three, at M18 were still on-going (Influenza, West Nile and Dengue). In WP3 (UCLH), progress reported by all clinical partners concerns the identification of samples to be tested at the next stage, recruitment of evaluation sites and submission of ethical forms for approval by the relevant committees. Within WP4, PKNM has provided and accomplished all relevant tasks, which are related to the regulatory design and implementation canvas of the products to be developed under this project. During that period, appropriate Regulatory guidance along with relevant QMS support was provided to all relevant partners, as per EU Regulation (2017/746). In WP5 (FORTH), we optimized an extraction-free assay for the detection of West Nile virus in mosquito samples, for testing with real samples both in the lab and the field. WP6 has implemented and made progress in analyzing two surveys, one with 3300 general public respondents in three countries and the second with 662 health workers in Norway. WP6 teams have also conducted qualitative interviews among health care workers in France, with additional ones planned in Norway. Teams have also made considerable progress in interviewing marginalized populations’ (older adults, migrants) priorities for POC diagnostics and pandemic preparedness WP7 (HBIO) reports considerable progress in the dissemination and communication of the project results through the website, the social media strategy and the active participation in 14 relevant events and conferences across Europe. In WP8 (BIOPIX), the strategy for rapid production and distribution of the technologies to be developed within UniHealth is presented, together with a plan for IP management including freedom-to-operate. Finally, within WP9 (FORTH), actions related to the management of the project results and the data produced are presented, including the first report of the Data Management Plan.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

UniHealth is advancing point-of-care diagnostics well beyond current commercial offerings. Most existing platforms rely on complex and costly technologies, such as microfluidics and fluorescence detection, which require advanced infrastructure and trained personnel. In contrast, UniHealth’s approach leverages simplified hardware and robust molecular chemistry to deliver highly sensitive diagnostics that are affordable, user-friendly and suitable for decentralized settings.

A key innovation is the development of a patented real-time colorimetric LAMP platform (Pebble) and a novel pocket-sized device. These tools eliminate the need for complex cartridges or fluorescence detection, using visual color changes and simple electronics to achieve accurate results. Their modular design supports rapid scaling and manufacturing, including in low-resource regions. Importantly, the pocket-sized device can operate on a standard power bank, making it ideal for remote or mobile testing scenarios.

In parallel, UniHealth is pioneering the use of DAMP (dual-priming isothermal amplification), an advanced molecular assay method that improves specificity and sensitivity. This novel chemistry is further enhanced by a universal reagent mix compatible with diverse crude sample types—from saliva and blood to mosquito tissue—allowing for wide-ranging applications with minimal sample preparation.
The integration of these diagnostic tools with a digital surveillance dashboard represents another step forward. Each test result can be geo-tagged and uploaded in real time, enabling health authorities to monitor outbreaks as they emerge and coordinate timely responses. The project also introduces a new approach to co-develop diagnostics with end users, incorporating feedback from healthcare professionals and communities to ensure high acceptance, usability and trust.

Together, these advances represent a transformative step toward democratizing molecular diagnostics and enabling global health systems to respond more effectively to emerging infectious threats.