Coeliac Disease Management Monitoring and Diagnosis* (CD-Medics)

Published on: 25/07/2011
Document

*Full title: Coeliac Disease Management Monitoring and Diagnosis using Biosensors and an Integrated Chip System

 

The overall concept of the CD-MEDICS IP is to develop a technology platform for point-of-care diagnostics, capable of simultaneous genomic and proteomic detection, with embedded communication abilities for direct interfacing with hospital information systems. This will be achieved by exploiting breakthroughs at the confluences of bio-, micro- and nano- technologies to create a low-cost non-invasive intelligent diagnosis system.

This platform will be developed in a modular format, which will allow each module to be developed and exploited individually. The modules will subsequently be integrated to facilitate the desired application. Advances in data communications, molecular biology and biosensor technology, with the integration of nanostructured functional components in macro and microsystems, will facilitate the realisation of a minimally invasive generic platform, which is capable of multi-parametric monitoring and will be interoperable with electronic medical records.

The advantages of integrated biosensor systems include their ease of use, their sensitivity, their inherent selectivity (preventing problems due to interfering substances), their versatility (allowing 'in-field' use) and their cost effectiveness. Addressing the future health care requirement of an individualised theranostic approach, the specific application that will be demonstrated in this IP will be for the management, monitoring and diagnosis of coeliac disease, with the proposed technology contributing to significant advances in sensitivity and specificity of diagnosis. The technology platform developed, however, could be applied to a variety of clinical screening applications, such as cancer. The radical innovation proposed in this IP will result in a concrete prime deliverable of a technology platform of wide application and unquestionable socio-economic benefit, increasing European competitiveness whilst contributing considerably to the quality of life well being of the population.

Policy Context

Problem or Context: Coeliac Disease is an autoimmune condition which affects 1 in 100 people in Europe. It is characterised by an intolerance to die­tary gluten found in wheat, rye and barley. This manifests itself in varied symptoms, many of which are quite debilitating, which makes it very diffi­cult to diagnose. Some estimates show that it can take over 10 years for a dia­gnosis to be made. The only treatment is a gluten free diet.

Project: CD-MEDICS will develop a point of care instrument that will both test for the genetic predisposition to the disease as well as the levels of auto­antibodies related to it. These antibody levels can then be used for monitoring and management of the disease, following withdrawal of gluten from the diet. This will be performed on a disposable microsystem using a single drop of blood within a portable instrument in a primary care setting.

Description of the way to implement the initiative

The overall objective of CD-Medics is the development of a portable device for multi-analyte screening of coeliac disease. The system will be built around a Lab-on-a-Chip platform capable of simultaneous detection of nucleic acids (HLA typing) as well as proteineous molecular markers (auto-antibodies), and will provide information as to the genetic predisposition as well as the early diagnosis of the coeliac disease patient. This platform will be developed in a modular format, which will allow the instrument to be used in a variety of locations and enable various instrument configura­tions to be realised.

Thus, the combined integrated device could be used for general population screening, or just the HLA typing microsystem could be used for neonatal screening; or alternatively just the auto-antibody microsystem could be used for monitoring compliance with the identified diet, or recurrence of the disease due to non-compliance.

The proposed combination of serology and HLA-typing is the only defini­tive way to screen for coeliac disease; a combined diagnosis accounting for symptomatic, silent and latent CD patients aims for 100% specificity and sensitivity.

A core component of the diagnosis system is a lab-on-a-chip disposable. This enables the user to introduce a drop of blood to the device, insert it in the instrument and run the diagnostic test. The lab-on-a-chip device looks like a simple piece of plastic but incorporates comprehensive intelligence: including a microstructured fluidic network allowing for a precisely controlled flow of reagents, a specifically adapted surface for capture the target biolo­gical markers, and finally electrochemical biosensor arrays, to enable an integrated and extremely fast detection.

The project also aims to incorporate communications that are capable of seamlessly operating in all point-of-care-driven environments (e.g. clinical laboratories, hospitals, physicians' offices) and trans­parently communicating with existing Hospital Information Systems (HIS) and patient's Electronic Health Record (EHR). This approach will allow for the integration of the information collected by the PoC device with the patient's EHR content, and better analysis and interpretation of the measurement results. A fully functional prototype device will tested in the clinical environment with real patient samples and interfaced to the hospitals electronic patient record system.

Main results, benefits and impacts

Key project goals:

  • Improved sensitivity and specificity of autoantibody assays and multi­plex HLA typing protocols for diagnosis and management of coeliac disease
  • Nanostructured biosensor arrays to realise ultrasensitive levels of detection
  • Individual micromodules for sample treatment, mixing, metering, nucleic acid amplification, HLA typing and autoantibody detection
  • Microsystem integrating sample treatment, handling and detection with biosensor arrays
  • Portable instrument embedded with communication abilities for connec­tivity with electronic patient record systems
  • Dissemination and training of public and healthcare professionals

The specific objectives of CD-MEDICS are:

  • Demonstration of usefulness of anti-glutenin antibodies to improve sensitivity and selectivity in the screening and diagnosis of coeliac disease and development of immunoassays and HLA typing protocols.
  • Development of a generic genosensor array micromodules for HLA typing.
  • Development of individual micromodules for sample treatment, mixing, metering, nucleic acid amplification, HLA typing and autoantibody detection.
  • Development of a nanostructured microsystem with multiple sample treatment modules integrated with the sensor arrays on a single disposable device.
  • Provision of a wireless communication approach that seamlessly links devices through one of many potential methods ensuring that communication capabilities are always maximised.
  • Clinical evaluation encompassing both end-user feedback and bioethical issues.
  • Innovation management ensuring exploitation of developed technology.
  • Integration of multidisciplinary education and skills development with research activities.
  • Ethical scrutiny and fostering of dialogue as a means of generating both greater appreciation of the contribution to our well-being of advanced technology and an enthusiasm for science.

 

Expected Results & Impacts

  • Improvement in the quality of life for coeliac disease sufferers
  • Reduction in health care provision costs
  • Generic Technological platform that is transferrable to a plethora of other applications

Reducing the time for diagnosis and regular monitoring will enable a considerable improvement in the quality of life for CD sufferers. Many suffer for decades with irrecoverable complications. Studies have shown that the cost of undiagnosed CD is very high. In Holland 5 of the long term implications of CD cost € 9 million to the healthcare system. The technology under development has considerable applications outside of coeliac disease. Indeed almost any genetic or serology test could be run on the platform with appropriate assays, making the technology very powerful and commercially viable.

Lessons learnt

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

Scope: International