Advancing point-of-care diagnostics to the market

POC diagnostic tests that are easy to use, affordable and can rapidly diagnose diseases will lead to more timely treatment and thereby reduce mortality, morbidity, and transmission of diseases. POC diagnostic tests should improve the quality of healthcare for resource-poor communities in developing countries, where the burden of disease is the highest. A diagnostics gap for many diseases affecting SSA still exists and needs to be closed urgently to contribute the global and national disease elimination targets.

Hence, proposals submitted under this topic should implement clinical studies that lead to market authorisation of the relevant POC diagnostic test. The POC diagnostic test device should be aimed at detection of diseases that currently lack POC diagnosis tests or where POC diagnostics are inadequate. Tests that can in the same specimen simultaneously and rapidly detect and thereby distinguish a wide range of diseases for improved clinical decision-making are encouraged (e.g. distinction between bacterial versus viral pathogens). The POC diagnostic tools are expected to be affordable and suitable for use in SSA countries. POC diagnostics for all diseases in scope of the current Global Health EDCTP3 programme^[1], for example antimicrobial resistance and emerging diseases, are included in this call (exception is Ebola Virus disease, covered under topic HORIZON-JU-GH-EDCTP3-2023-01-04).

Proposals should address all of the following areas:

• Clinical performance studies in several sites across SSA of POC diagnostics that are of high technology readiness level to achieve regulatory approval and market launch (i.e. CE mark); post-market surveillance studies are excluded from this call and are covered by other initiatives such as the African Health Diagnostics Platform^[2];
• Studies need to provide evidence-based practice for the POC diagnostic test especially in terms of the ability to decide on treatment options after diagnosis and improving disease outcome; the possibility of the POC diagnostic to be deployed in the field, its usability by primary care and community health care workers in resource-limited patient communities should be especially considered;
• Inclusion of a clear regulatory path to market to ensure future compliance with the legal requirements; early engagement with regulatory authorities is expected;
• Product development plans for translation from prototype to industrial design, to implementation and sustainability of the innovation should be provided, also including a plan for the process of “sample to result to the use of result & treatment option” and how to report data & results (e.g. via mobile health/portable technology);
• Where available and relevant, World Health Organization target product profiles for diagnostics need to be addressed^[3];
• Involvement of industry, notably of small and medium-sized enterprises (SMEs), especially African SMEs, is expected. Involvement of African SMEs is highly encouraged to contribute to developing the African industry and access to health products.^[4]

Proposals submitted under this topic are encouraged to consider innovative diagnostics sampling methods or samples bringing a significant improvement, such as less invasive sampling methods and self-testing at home. The POC diagnostic should allow for easy storage, such as at room temperature. Consideration of environmental friendliness of diagnostic tests would be advantageous. Transmission and economic modelling to examine the impact of the POC diagnostic assay on performance of long-term health outcomes and cost-effectiveness could be envisioned. Relevant partnerships with local and international organisation to create solutions for improved deployment of diagnostics for vulnerable populations in low-resource settings could be sought.

In addition, where relevant, the link between the diagnostic devices to relevant infectious disease surveillance strategies to inform public health authorities and advise public health policies should be made. This can include monitoring the impact of relevant POCs on the use of antibiotics.

For all proposed research activities, attention should be paid to critical social factors such as sex, gender, age, socio-economic factors, ethnicity/migration, and disability. Populations for POC diagnostic test development and evaluation of the POC diagnostic test performance and appropriateness should also include vulnerable populations, including children, pregnant women, people with co-infections and co-morbidities, older people, and people living in hard-to-reach communities. Rapid feedback from end-users through community engagement on the performance and acceptance of the technologies and their most effective use in endemic settings is expected.

Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results. Building on relevant results from projects supported under previous EDCTP programmes is encouraged.

Proposals are expected to come from research consortia with a strong representation of institutions and researchers from African countries, including involvement of franco/lusophone countries where possible and relevant.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Global Health EDCTP3 Joint Undertaking may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

[1]https://commission.europa.eu/system/files/2022-01/ec_rtd_edctp3-sria-2022.pdf

[2]AHDP - AFRICAN HEALTH DIAGNOSTICS PLATFORM (eib.org)

[3]The list of target product profiles that have been developed by the World Health Organization can be accessed at: https://www.who.int/observatories/global-observatory-on-health-research-and-development/analyses-and-syntheses/target-product-profile/links-to-who-tpps-and-ppcs; please note that this list includes target product profiles for different types of healthcare interventions.

[4]The Team Europe initiative (TEI) on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+) https://europa.eu/capacity4dev/tei-jp-tracker/tei/manufacturing-and-access-vaccines-medicines-and-health-technology-products-africa