MULTIFUNCTIONAL MICROFLUIDIC PATCH FOR INFECTIOUS DISEASES DIAGNOSIS

Project Information

FORTIFIEDx

Grant agreement ID: 101092049

DOI

10.3030/101092049

EC signature date 5 September 2023

Start date 1 August 2023

End date 31 July 2027

Funded under

• Digital, Industry and Space

Total cost

€ 4 986 073,83

EU contribution

€ 4 986 070,00

Coordinated by

KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium

Periodic Reporting for period 1 - FORTIFIEDx (MULTIFUNCTIONAL MICROFLUIDIC PATCH FOR INFECTIOUS DISEASES DIAGNOSIS)

Reporting period: 2023-08-01 to 2025-01-31

Summary of the context and overall objectives of the project

The FORTIFIEDx project aims to revolutionize the point-of-care in vitro diagnostic (POC IVD) field by making use of novel multifunctional biocompatible polymers and their (micro)structuring with mass fabrication technology to develop for the first time a true sample-to-result POC test.

IVD technologies have revolutionized healthcare, yet remain confined to the laboratories. As witnessed during the COVID-19 pandemic, this traditional centralized approach was not sufficient to prevent and manage viral outbreak because it massively failed to deliver quick and cost-effective diagnosis. The pandemic further emphasized the growing need to urgently bring lab-quality diagnosis to the hands of end users (i.e. at the POC).

The FORTIFIEDx consortium will develop a FORTIFIEDx microfluidic-based patch capable of both biofluids (self-)sampling via hollow microneedles (HMN) and immediate analysis of this sample on the very same patch in a completely self-powered manner. Two unmet clinical needs, posing epidemic/pandemic treats to both the dFORTIFIEDx eveloped and developing world, are selected: (1) sexually transmitted diseases, in particular simultaneous diagnosis of HIV and Syphilis, to enable timely diagnosis of patients not always able to reach centralized settings due to stigma or financial difficulties and (2) viral haemorrhagic fever (VHF), in particular Ebola and Lassa viruses (EBOV and LASV, respectively), to battle their highly contagious and deadly outbreaks, prevalent in low-middle income countries (LMIC) where resources are scarce and investment in healthcare is low.

To tackle this challenging aim, the interdisciplinary and experienced FORTIFIEDx consortium will combine insights from material science, engineering and microfabrication, microfluidic technology development, bioassay development, clinical validation and life cycle assessment (LCA).

Our vision is to address these 2 clinical gaps by offering a novel technology-based approach to revolutionize the diagnostics workflow, from centralized towards decentralized and more patient empowerment. With our interdisciplinary approach, we aim to cover the whole value chain of a novel IVD patch from its engineering and material side until its validation with clinically relevant applications. For this reason, it is anticipated that our impact will be extensive, touching different growing markets, engaging with academic, industrial and societal stakeholders.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the FORTIFIEDx project, we have been working on studying the use of novel biocompatible polymer material for developing next generation microfluidic chips. In this context, we have achieved low temperature bonding, fast curing rates and sufficiently high storage stability of a material, which is compatible with high throughput fabrication method for delivering microfluidic FORTIFIEDx patches. In addition to this, several essential microfluidic elements have been established for on-chip metering, dilution and bioassay integration, hence providing a flexible microfluidic toolbox that can accommodate different bioassays of this project, namely molecular bioassays (i.e. RPA) for detecting EBOV and LASV as well as immunoassays for HIV and Syphilis detection. In order to accomplish biofluid sampling as integral part of the FORTIFIEDx patch, we also studied innovative microfabrication approaches for generating out-of-plane HMN arrays made of biocompatible materials, developing so far prototypes for testing skin penetration and sampling. Furthermore, we have made significant progress in developing materials and methods for reactive inkjet printing (RIP) aiming to have tunable flexibility of microfluidic chips. Next, an effort has been invested in establishing different bioassays. Namely, commercially available HIV and syphilis immunological-bioassays have been downscaled for their integration on the (i)SIMPLE chip with successfully validation of patient samples, whereas RPA bioassays for EBOV and LASV are in development phase with initial proof-of-concepts achieved. Finally, as part of this project, we aim to investigate the environmental impact of the FORTIFIEDx patch using an LCA in terms of (1) material and energy consumption for its fabrication and (2) generated change in the IVD workflow, with first LCA steps of the FORTIFIEDx patch production being done, including the definition of system boundaries, functional unit and identification of material and energy flows.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The FORTIFIEDx project will contribute with its results beyond the state of the art to the following impacts:
• New sustainable-by-design materials with enhanced functionalities and applications in a wide range of industrial processes and consumer products. Although the application selected in the FORTIFIEDx project, namely IVD device for infectious diseases, requires disposable consumables, excludes recycling of used materials and obliges for strict disposing measure (e.g. incineration), the polymer investigated in this project, can be considered sustainable-by-design material. Moreover, selected material holds potential for many more different industrial fields, on top of the microfluidics and IVD exploited in the FORTIFIEDx project, such as medical devices, rapid prototyping, functional coatings, soft robotics/actuators, reversible adhesives. Moreover, as one of the FORTIFIEDx results, the LCA analysis planned on the FORTIFIEDx chip will investigate quantitatively the hypothesis described above about higher material sustainability.
• Increased adoption of key digital and enabling technologies in industrial value chains and strategic sectors, paying particular attention to SMEs and start-ups. In FORTIFIEDx, we will push the high-throughput fabrication of microfluidic chips and the use of innovative material as key enabling technologies, particularly for the 2 contributing SMEs that open very new strategic fields within the sector of bio-functional microfluidic devices for life science application. The close collaboration between the SMEs and the research partners will take into account the aspects of smart automation and digital interconnectivity that enforces the transfer and adoption of brand new and digital technologies on the SMEs side and allow to set up value chains that bring the innovations closer and faster to the border of market introduction.

FORTIFIEDx value chain