Cross-cutting KETs for diagnostics at the point-of-care

The focus is on further development into a clinical setting of novel MNBS platforms, techniques and systems that have already been proven in a laboratory setting (laboratory Proof-of-Concept). These must pertain to one or more of the following:

1. In vitro/in vivo diagnostics that are deployed at the point of care;
2. Therapy monitoring at the point of care.

Proposals should pay attention to facilitate clinical data harvesting, e.g. for medical regulatory purposes and/or to enhance epidemiological monitoring of health and disease patterns. As relevant, the proposed activities should address sex and gender specific aspects[[See definition of the 'gender dimension approach' in the introduction of this Work Programme part.]].

Proposals should demonstrate clear compliance with applicable Good Laboratory Practice /Good Clinical Practice /Good Manufacturing Practice, and be consistent with ISO and other regulations (both national and European). The translation from the pre-clinical phase to early clinical testing, including design and pilot manufacturing in appropriate volume for clinical testing (small series), pre-clinical and early clinical testing is a necessary part of the work-up. Attention should be paid to the requirements for Health Technology Assessment (HTA). Standardisation issues have to be taken into account where appropriate.

Activities are expected to commence at Technology Readiness Levels 3/4 and reach 5-6.

A significant participation of SMEs with R&D capacities is encouraged.

The Commission considers that proposals requesting a contribution from the EU between EUR 3 and 5 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Research and technology development at the interface of key enabling technologies has the potential to provide novel technological Micro-Nano–Bio integrated Systems (MNBS) platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, organ, tissues) to nano scale (e.g. molecules, genes). These developments have a high potential for facilitating personalised and preventive healthcare. However, the translation of laboratory proven concepts to the clinical environment involving pre-clinical and clinical testing, prototyping, and small series manufacturing is currently lagging. Business development and market growth are therefore still limited. The challenge is to bring new promising laboratory proven MNBS concepts for addressing priority healthcare needs from the laboratory to the clinic.

Proposals should address one or more of the following impact criteria and provide metrics to measure and monitor success.

• Address priority needs in healthcare diagnostics and / or therapy monitoring, for the benefit of patients;
• Provide affordable systems with unique features that address specific well identified requirements in healthcare;
• Progress the development of advanced integrated MNBS based diagnostic health platforms, techniques or systems from the laboratory Proof-of-Concept to the clinical setting;
• Establish a world-class European competitive industrial R&D and manufacturing competence in Micro-Nano-Bio Systems integration for healthcare diagnostics applications;
• Strengthening the industrial value chain and progress to marketisation;
• Early involvement of regulatory bodies and patients in the new developments.

Proposals should include a business case and exploitation strategy, as outlined in the Introduction to the LEIT part of this Work Programme.

This topic will be co-funded by LEIT-ICT and LEIT-NMBP within the context of a Cross-KET initiative for Health, for a total budget of EUR 15 000 000.