Portable and versatile Point-of-care diagnostics

The Horizon Europe call titled "Portable and Versatile Point-of-Care Diagnostics" under topic ID HORIZON-HLTH-2027-02-IND-02-two-stage, is an Innovation Action with a total budget of €39.3 million, designated for development, clinical validation, and commercialization of point-of-care diagnostic devices. The submission process will be two-stage, opening on February 10, 2027, with stage one proposals due by April 13, 2027, and stage two proposals by September 22, 2027. The funding amount for each grant ranges from €5 million to €7 million, with a focus on six expected grants.

Eligible applicants include various stakeholders, such as SMEs, large enterprises, universities, research institutes, and healthcare providers, who must form consortia typically consisting of at least three partners from different countries. Notably, legal entities from the United States are also eligible, while entities controlled by China are excluded.

The call primarily targets the health sector, focusing on innovative technologies for point-of-care testing, particularly for infectious and non-communicable diseases. The proposals should represent a clear clinical need, with emphasis placed on integration of mobile technologies and AI solutions, following the World Health Organization’s REASSURED criteria which stress real-time connectivity, sensitivity, affordability, and user-friendliness.

Successful proposals must include three main activities: optimization of diagnostic devices, conducting comparative clinical studies against current methodologies, and executing clinical validation with regulatory compliance under the EU's In-Vitro Medical Device Regulation (IVDR) or Medical Device Regulation (MDR).

The evaluation process involves a blind review of initial proposals, looking for excellence and impact, while the second stage will assess the projects based on additional parameters including implementation. Each proposal must comply with specific eligibility conditions and include details regarding financial and operational capacity. The funding is designed as a lump sum, simplifying financial management for awarded projects.

Overall, the initiative aims to enhance diagnostic capabilities and patient outcomes within the EU, particularly in resource-restricted healthcare environments.

This is a Horizon Europe call for proposals under the Cluster 1 Health, specifically targeting "Portable and versatile Point-of-Care diagnostics" with the topic ID HORIZON-HLTH-2027-02-IND-02-two-stage. It is a HORIZON Innovation Action (HORIZON-IA) and uses the HORIZON Lump Sum Grant [HORIZON-AG-LS] funding mechanism. The call follows a two-stage submission process and is planned to open on 10 February 2027, with deadlines on 13 April 2027 and 22 September 2027.

The call aims to support activities that contribute to "Maintaining an innovative, sustainable, and competitive EU health industry". The expected outcomes include:

Healthcare professionals having access to point-of-care diagnostic tools for faster therapeutic decision-making.
Patients benefiting from quick and accurate diagnoses, leading to improved health outcomes.
Health systems gaining better evidence for disease control and prevention through more efficient diagnostics.

The scope of the call focuses on Point-of-Care (PoC) medical testing, acknowledging the progress made in areas like extraction, microfluidics, miniaturization, and data processing. While PoC test accuracies are approaching lab-based tests, challenges remain, including false results and cumbersome sample preparation. The call emphasizes the need for more sensitive, selective, and easy-to-use PoC diagnostics.

The call refers to the World Health Organization (WHO) REASSURED criteria for PoC diagnostics: 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. It also highlights the importance of "sample-to-answer" solutions and addresses challenges such as miniaturization, power supply, versatility, biocompatibility, mass production suitability, high-throughput testing readiness, quality control, regulatory compliance, environmental footprint, and cost-effectiveness, especially in resource-limited settings. The role of mobile technologies and Machine-Learning/Artificial Intelligence (ML/AI) powered algorithms in PoC diagnostics is also acknowledged.

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

Optimizing targeted PoC diagnostic devices, considering the REASSURED criteria and associated challenges.
Elaborating a comparative study demonstrating the added value and improved performance of the optimized PoC devices compared to the current state of the art.
Conducting clinical studies for clinical validation and subsequent conformity assessment in agreement with EU In-Vitro Medical Device (IVDR) or Medical Device (MDR) regulatory requirements.

Priority will be given to approaches suitable for resource-limited settings and, in the case of infectious diseases, those enabling the distinction between viral, bacterial, or fungal infections. For non-communicable diseases, priority is given to approaches used in emergency cases.

Applicants invited to the second stage and planning to include clinical studies should provide details in a dedicated annex.

General conditions for participation include:

Admissibility conditions as described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout as described in Part B of the Application Form.
Eligible countries as described in Annex B of the Work Programme General Annexes, with specific provisions for non-EU/non-Associated Countries.
Eligibility of US-based entities due to the opening of NIH programs.
Mandatory use of Copernicus and/or Galileo/EGNOS for projects using satellite-based data.
Restrictions on entities controlled by China.
Financial and operational capacity and exclusion criteria as described in Annex C.
Blind evaluation of first-stage proposals.
Award criteria, scoring, and thresholds as described in Annex D.
Submission and evaluation processes as described in Annex F and the Online Manual.
Indicative timeline for evaluation and grant agreement as described in Annex F.
Potential objection to transfer of ownership or exclusive licensing of results within 4 years after the action's end.
Eligible costs will take the form of a lump sum.
Legal and financial set-up of the grants as described in Annex G.

Application and evaluation form templates, guidance documents, and additional resources are provided, including the HE Programme Guide, Model Grant Agreement, call-specific instructions, information on clinical studies, detailed budget table, guidance on lump sums, ownership control declaration, and relevant work programmes and regulations.

The budget overview indicates that the HORIZON-HLTH-2027-02-IND-02-two-stage topic has a budget of 39,300,000 EUR for the year 2027, with contributions ranging from 5,000,000 to 7,000,000 EUR and an indicative number of 6 grants.

Partner search announcements are available for collaboration on this topic.

In summary, this Horizon Europe call aims to foster the development and optimization of portable and versatile point-of-care diagnostic devices. It seeks to improve healthcare outcomes by enabling faster and more accurate diagnoses, particularly in resource-limited settings and for both infectious and non-communicable diseases. The call encourages proposals that integrate clinical needs, value-based concepts, and adhere to relevant regulatory requirements, while also prioritizing user-friendliness, affordability, and accessibility. The funding is provided as a lump sum, and the call follows a two-stage submission process.

Eligible Applicant Types: The eligible applicant types are not explicitly stated in the provided text. However, based on the nature of Horizon Europe and the type of action (Innovation Actions), eligible applicants could include: startups, SMEs, large enterprises, universities, research institutes, and other legal entities capable of conducting research and innovation activities in the health sector. The text mentions the Enterprise Europe Network which provides advice to businesses with special focus on SMEs, suggesting that SMEs are encouraged to apply.

Funding Type: The funding type is a grant, specifically a HORIZON Lump Sum Grant, as indicated by the Type of MGA (Model Grant Agreement) being HORIZON Lump Sum Grant [HORIZON-AG-LS]. This means that eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021.

Consortium Requirement: The text does not explicitly state whether a single applicant or a consortium is required. However, given the scope and nature of Innovation Actions, a consortium is more likely to be successful, as it allows for a broader range of expertise and resources. The presence of a "Partner Search" function also suggests that consortia are anticipated.

Beneficiary Scope (Geographic Eligibility): 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. 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. Therefore, the geographic eligibility includes EU member states, associated countries, and potentially other non-EU countries with specific provisions, including the United States of America.

Target Sector: The target sector is health, specifically focusing on point-of-care (PoC) diagnostics. The program targets the development and optimization of PoC diagnostic devices for both infectious and non-communicable diseases. The thematic or industry sectors include health, biotech/medtech, pharma/healthcare, ICT (related to real-time connectivity and data processing), artificial intelligence (ML/AI powered algorithms), and innovation.

Mentioned Countries: The United States of America and China are explicitly mentioned. The text also refers to developing countries as areas in direct need of advanced and more accessible PoC diagnostics.

Project Stage: The project stage is primarily development and innovation. The scope includes optimizing existing PoC diagnostic devices, conducting comparative studies, and performing clinical studies for validation and conformity assessment. The projects are expected to advance the technology readiness level (TRL) of PoC diagnostics towards commercialization.

Funding Amount: The budget overview provides the following information:
HORIZON-HLTH-2027-02-DISEASE-01-two-stage: €7,000,000 to €8,000,000 (8 grants)
HORIZON-HLTH-2027-02-DISEASE-14-two-stage: Around €10,000,000 (4 grants)
HORIZON-HLTH-2027-02-IND-02-two-stage: €5,000,000 to €7,000,000 (6 grants)
HORIZON-HLTH-2027-02-TOOL-01-two-stage: €6,000,000 to €8,000,000 (6 grants)
The funding range is variable, from €5 million to around €10 million, depending on the specific topic.

Application Type: The application type is an open call with a two-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves two stages. In the first stage, proposals are evaluated blindly. Applicants invited to the second stage provide more detailed information, including details of clinical studies if applicable.

Success Rates: The success rates are not explicitly mentioned. However, the text indicates the indicative number of grants for each topic, which can be used to estimate the potential success rate based on the number of applications received. 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.

Co-funding Requirement: The text does not explicitly state whether co-funding is required. However, as a Horizon Europe action, co-funding may be implied, and applicants should consult the relevant annexes and work program documents for specific co-funding requirements.

Summary: This Horizon Europe funding opportunity aims to improve point-of-care (PoC) diagnostics to support a competitive EU health industry. It focuses on developing and optimizing portable, versatile, and user-friendly PoC devices that provide fast and accurate diagnoses for both infectious and non-communicable diseases. The projects should address the criteria defined by the World Health Organization (WHO), integrate mobile technologies and AI, and be driven by a clear clinical need and value-based concept. The funding is provided as a lump sum grant, and the application process involves two stages, with the first stage being a blind evaluation. Eligible applicants include a range of organizations, such as startups, SMEs, research institutes, and universities, primarily from EU member states and associated countries, with specific provisions for entities from the United States. The projects should optimize PoC devices, conduct comparative studies, and perform clinical studies for validation and conformity assessment, ultimately leading to improved healthcare outcomes and more efficient disease control strategies.