Portable and versatile Point-of-care diagnostics

Topics under this destination are directed towards the Key Strategic Orientation 3 “A more resilient, competitive, inclusive, and democratic Europe” of Horizon Europe’s strategic plan 2025-2027^[1]. In addition, Key Strategic Orientation 2 “The Digital Transition” and Key Strategic Orientation 1 “The Green Transition” are supported.

Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “the EU health industry is innovative, sustainable, and globally competitive thanks to improved uptake of breakthrough technologies and innovations (including social innovations) that make the EU with its Member States and Associated Countries more resilient and less reliant on imports of critical health technologies”.

The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of healthcare services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. high attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for Research and Innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).

In line with the Commission's Political Guidelines for 2024-2029^[2], and building on the recommendations of the reports by Mario Draghi^[3] and Enrico Letta^[4], as well as the “Strategy for European Life Sciences”^[5], this destination will support research and innovation to enhance the competitiveness of the European health industry, thereby reinforcing EU autonomy, consolidating its Single Market, and empowering Europe to effectively address the burden of both communicable and non-communicable diseases. In this Work Programme part, Destination “Maintaining an innovative, sustainable, and competitive EU health industry” focuses on collaborative efforts to advance cell-free protein synthesis platforms, ready-to-use point-of-care diagnostics, and regulatory science to support translational development of patient-centred health technologies. The results will support the EU Industrial Policy, with a focus on strengthening the resilience of the single market, addressing the EU’s strategic dependencies, gaining technological sovereignty and accelerating the green and digital transitions. The results will further strengthen the single market, by providing evidence and guidelines for stakeholders and regulators to ensure adoption of innovations, supporting environmental, fiscal and socio-economic sustainability and at the same time fostering healthcare access and reducing health inequities. The results will also support the implementation of the relevant Regulations like those on Medical Devices (MDR) and In-Vitro Medical Devices (IVDR) as well as the general uptake of innovative health technologies by health systems, with a special view to aspects related to ensuring industry competitiveness, fostering innovation and sustainability, while maintaining the high level of quality, safety and efficacy of these health technologies.

In view of increasing the impact of EU investments under Horizon Europe, the Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, development and adoption of best practices, or joint communication activities. All topics are open to international collaboration to address global environment and health challenges.

Expected impacts:

Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and competitive EU health industry, and more specifically to one or several of the following expected impacts:

• Health industry in Europe and Associated Countries is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and (digital) technologies, contributing to job creation and economic growth, in particular with small and medium-sized enterprises (SMEs)^[6].
• Health industry is supported by cross-sectoral Research and Innovation in the context of convergence of health technologies (integrating medical technologies, pharmaceuticals, biotechnologies, digital health, and e-health technologies) while strengthening key market positions.
• Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, healthcare providers, health authorities and regulators ensuring suitability and acceptance of solutions.
• Citizens, healthcare providers and health systems benefit from a swift uptake of innovative health technologies and services through the provision of evidence and guidelines for stakeholders, policymakers and regulators. These efforts offer significant improvements in health outcomes, also potentially strengthening access to healthcare for all and reducing health inequities while health industry benefits from decreased time-to-market.
• Citizens, healthcare providers and health systems benefit from increased health security in Europe and Associated Countries due to reliable access to key manufacturing capacity, including timely provision of essential medical supplies and technologies of particularly complex or critical supply and distribution chains.

Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme.

The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers^[7] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.

[1] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/strategic-plan_en

[2] https://commission.europa.eu/about/commission-2024-2029_en

[3] The future of European competitiveness, Mario Draghi: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en

[4] Much more than a market, Enrico Letta: https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf

[5] https://research-and-innovation.ec.europa.eu/strategy/strategy-research-and-innovation/jobs-and-economy/towards-strategy-european-life-sciences_en; https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686

[6] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361

[7] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:

• Healthcare professionals dispose of diagnostic tools at the point of care that accelerate therapeutic decision making.
• Patients benefit from fast and accurate diagnosis leading to improved health outcomes.
• Thanks to more efficient diagnosis, health systems will get better evidence for disease control and prevention strategies.

Scope:

Point-of-Care (PoC) medical testing has made great technical progress (e.g. improved extraction, microfluidics, miniaturisation, and data processing techniques) with PoC test accuracies nearly matching those of lab-based tests. PoC tests may thus be an alternative to laboratory testing methods, enabling faster diagnostic results and therapeutic decision making. However, PoC testing is not always achieving a completely accurate diagnosis and one of the major issues with PoC diagnostics is the occurrence of false results during testing, another one is the often-cumbersome sample preparation. Hence there is a need for PoC diagnostics that are more sensitive, selective and easy-to-use allowing for improved clinical practice.

The World Health Organization (WHO) has defined a set of criteria for PoC diagnostics in primary care which, in the advent of digital technologies, has been completed with two additional features and is represented by the acronym REASSURED: Real-time connectivity, Ease of specimen collection and environmental friendliness, Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free (or equipment-modest) and Deliverable to end users. To these criteria adds the feature of “sample-to-answer” (sometimes also called “sample-to-result”) and more challenges like: Miniaturisation, power supply, versatility (nature and origin of the human sample), biocompatibility of the used materials and their suitability for mass production, readiness for high-throughput testing, quality control, regulatory compliance, environmental footprint and, last but not least, cost, which is of particular concern in resource-limited settings. All these challenges are not only valid for PoC diagnostics developed for infectious diseases, they equally apply to those that are designed to detect non-communicable diseases as well as their continuous monitoring on patients. Mobile technologies are playing an important role, especially since around 70% of the globally 7.4 billion cell phone users live in developing countries, which are the areas in direct need of advanced and more accessible PoC diagnostics (lower density of relevant health infrastructure, e.g. hospitals and laboratory medicine testing facilities). Mobile phones have not only been proposed and tested for data acquisition and readout of assays, images and other results but also for sample processing (e.g. for heating step), as have been Machine-Learning/Artificial Intelligence (ML/AI) powered algorithms that are integrated in the diagnostic devices to analyse complex biological data and detect patterns that might be missed by human analysis.

The selection of the PoC device to be developed or optimised should be based on an objectively conducted clinical needs assessment, which includes -next to clinicians’ perspectives- the complete care pathway and system-level needs. Moreover, a value-based concept should be applied in the choice and development of the PoC device, taking into account its Health Technology Assessment (HTA) by the relevant HTA bodies, in order to facilitate their decisions for adoption.

Proposals should be driven by a clear clinical need, integrate a value-based concept and include all the following activities:

• The optimisation of (the) targeted PoC diagnostic device(s) that take(s) the above-mentioned criteria, challenges and aspects into consideration.
• The elaboration of a comparative study clearly demonstrating the added value and improved performance of the optimised PoC diagnostic device(s) as compared to the current state of the art for the targeted diagnostic application.
• The conduct of clinical studies of (the) optimised PoC diagnostic medical device(s) as a preferred information source for their clinical validation; subsequent conformity assessment in agreement with requisite EU’s In-Vitro Medical Device (IVDR) or Medical Device (MDR) regulatory requirements.

In general, priority should be given to approaches that are suitable for resource-limited settings. In case of targeting infectious diseases, priority should be given to approaches enabling the distinction between viral, bacterial or fungal infections. In case of targeting non-communicable diseases, priority should be given to approaches that are used in emergency cases where decisions can have life-saving character.

Applicants invited to the second stage and envisaging to include clinical studies^[1] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.

[1] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.