Portable and versatile Point-of-care diagnostics

O čem je ta razpis?

The topic funds innovation projects that optimise portable point-of-care diagnostic devices, compare them with the state of the art and validate them clinically for regulatory conformity. Approaches suited to resource-limited settings have priority.

Kaj ta razpis financira?

Scope

The topic funds the optimisation and clinical validation of portable point-of-care (PoC) diagnostic devices that are more sensitive, selective and easy to use. Devices should respond to the WHO REASSURED criteria (real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, minimal equipment and deliverability) and to further challenges such as sample-to-answer operation, miniaturisation, power supply, mass production, regulatory compliance, environmental footprint and cost.

Expected activities

Proposals should be driven by a clear clinical need, apply a value-based concept that considers Health Technology Assessment, and include all of the following:

• Optimisation of the targeted PoC diagnostic device or devices.
• A comparative study showing added value and improved performance against the current state of the art.
• Clinical studies to validate the optimised device, followed by conformity assessment under the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR) or Medical Devices Regulation (MDR).

Priorities

• Approaches suitable for resource-limited settings.
• For infectious diseases, approaches that distinguish between viral, bacterial and fungal infections.
• For non-communicable diseases, approaches used in emergencies where decisions can be life-saving.

Expected outcomes

• Healthcare professionals have PoC tools that speed up therapeutic decisions.
• Patients receive fast and accurate diagnosis.
• Health systems obtain better evidence for disease control and prevention.

Kdaj je rok za oddajo?

17. februarja 2027 (103 dni)

Two-stage call: first-stage deadline 13 April 2027; second-stage deadline 22 September 2027.