Portable and versatile Point-of-care diagnostics

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: R eal-time connectivity, E ase of specimen collection and environmental friendliness, A ffordable, S ensitive, S pecific, U ser-friendly, R apid and robust, E quipment-free (or equipment-modest) and D eliverable 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.

Eligibility and submission conditions

"> General conditions 1. Admissibility Conditions, proposal page limit and layout Applicants submitting a proposal for a blind evaluation (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E). Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 2. Eligible Countries Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide . 3. Other Eligibility Conditions In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used). In line with the “ restriction on control in innovation actions in critical technology areas ” delineated in General Annex B of the General Annexes, entities established in an eligible country but which are directly or indirectly controlled by China or by a legal entity established in China are not eligible to participate in the action. Other eligibility conditions are described in Annex B of the Work Programme General Annexes. 4. Financial and operational capacity and exclusion Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. 5a. Evaluation and award: Award criteria, scoring and thresholds The first-stage proposals of this topic will be evaluated blindly. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget. For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual . 5c. Evaluation and award: Indicative timeline for evaluation and grant agreement Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. 6. Legal and financial set-up of the grants The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [This [decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf ]]. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions Specific conditions are described in the specific topic of the Work Programme. Application and evaluation forms and additional documents: Application and evaluation form templates Standard application form (HE RIA IA Stage 1 BLIND) - the application form specific to this call is available in the Submission System Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System Standard evaluation form (HE RIA, IA and CSA Stage 1 BLIND) - will be used with the necessary adaptations Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations Guidance HE Programme Guide Model Grant Agreement (MGA) Lump Sum MGA Call-specific instructions Information on clinical studies (HE) Detailed budget table (HE LS)   Guidance: "Lump sums - what do I need to know?" Ownership control declaration Additional documents HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health HE Main Work Programme 2026-2027 – 15. General Annexes HE Programme Guide HE Framework Programme 2021/695 HE Specific Programme Decision 2021/764 EU Financial Regulation 2024/2509 Decision authorising the use of lump sum contributions under the Horizon Europe Programme Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement

Programme context

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).

Hivatkozott dokumentumok

Annex A Horizon Europe Programme Guide Online Manual [This [decision Standard application form (HE RIA IA Stage 1 BLIND) Standard application form (HE RIA, IA) Standard evaluation form (HE RIA, IA and CSA Stage 1 BLIND) Standard evaluation form (HE RIA, IA) Lump Sum MGA Information on clinical studies (HE) Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" Ownership control declaration HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf