The SmartHEALTH Integrated Project (Smart Integrated Biodiagnostic Systems for Healthcare) developed and delivered the next generation of smart diagnostic systems fully integrated into healthcare systems in Europe. Driven by key applications in cancer diagnostics, SmartHEALTH enabled enhanced medical diagnosis leading to earlier and more precise results, thus contributing to an increased quality of life.

Description of the way to implement the initiative

In addressing the high economic burden of the healthcare sector, prevention, early diagnosis and informed therapeutics are indispensable. Tests must be highly accurate and well integrated into medical management to avoid unnecessary treatment and stress to users. SmartHEALTH addressed these complex issues by developing highly intelligent diagnostic technologies that are fully integrated into healthcare systems, optimising their impact in management and work practice. Driven by key targeted applications in cancer diagnostics (breast, cervical and colorectal), the project delivered prototype systems with the aim of moving instrumentation from the laboratory, through to portable devices localised at the "point of care".

SmartHEALTH technology provides new solutions for cancer monitoring. Cancers are not 'cured' but 'managed'. One of the major areas of progress with cancers, such as breast cancer, is the benefit of long-term therapies for reducing growth rates. This approach requires regular monitoring such that the efficacy of maintenance therapy is rapidly noted and different therapy can be initiated as required. This necessitates regular testing for cancer load. People wish to avoid hospital yet want results interpreted expertly and communicated rapidly. They want tests that do not miss problems yet avoid unnecessary worry. SmartHEALTH aims to develop such an integrated breast cancer monitoring diagnostic eventually useable in a localised and more available setting.

Driven by clinical applications and MNT & IST technology, SmartHEALTH developed an open integrated architecture for new biodiagnostic systems to support European companies exploiting bioassays or new application concepts. The initial system has a disposable fluidic cartridge with a desktop base-station linking to the ambient e-Health environment. This concept was miniaturised and cost engineered into a portable and more available product. It can perform multi-analyte sensing and interpretation, for nucleic acids and proteins and handles multiple biological sample types.

Main results, benefits and impacts

Results were interpreted and presented using bio-information analysis. Systems were healthcare 'user identity-' and 'ambient environment-' aware, respecting confidentiality and information access rights. The IP will enable enhanced medical diagnosis, leading to earlier and more precise results contributing to an increased quality of life as well as increasing the competitiveness of the European IVD sector. Clinical areas for SmartHEALTH application are in Cancer Diagnostics - breast cancer recurrence monitoring, cervical cancer case finding, and colorectal cancer diagnostics, theranostics and prognostics. Each application includes clinical validation and commercial exploitation partners.

SmartHEALTH objectives included:

• Introduce new SmartHEALTH sensor systems into future healthcare services to improve and better existing services.
• Demonstrate the role of Ambient Intelligent (AmI) medical devices and online services for pervasive healthcare provision
• Demonstrate clinical validation of systems for targeted applications in breast, cervical and colorectal cancer.
• Demonstrate the economic benefits and means of healthcare provision for the targeted clinical applications.
• Develop new manufacturing technologies for realisation of unique sensor solutions integrating fluidics, transducers and biological assays.

Lessons learnt

This field will be completed by the submitter when the lessons learnt have been identified and understood.