GSS EU Science Funding Gateway

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); postmarket surveillance studies are excluded from this call and are covered by other initiatives such as the African Health Diagnostics Platform;
• 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;
• Involvement of industry, notably of small and medium-sized enterprises (SMEs), especially African SMEs, is expected.

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.