EUROPE - (HealthTech Wire / News) - The European Commission has designated 9.5 million Euros for an eHealth project aimed at researching and advancing the diagnosis, monitoring and management of Coeliac Disease (CD). The four-year project ‘Coeliac Disease – Management, Monitoring and Diagnosis using Biosensors and an Integrated Chip System (CD-MEDICS)’ is funded under the umbrella of the EU’s Seventh Framework Programme for Research and Technological Development (FP7) and coordinated by Ciara O’ Sullivan of the Universitat Rovira I Virgili in Spain. It brings together 20 partners - including universities, hospitals and technology centers from Spain, Germany, United Kingdom, Greece, Italy, Sweden, Finland, Slovenia, Ireland and Belgium.
The project will exploit breakthroughs in bio-, micro- and nanotechnologies to create a low-cost, non-invasive intelligent technology platform for point-of-care diagnostics. The platform should be capable of simultaneous genomic and proteomic detection and feature embedded communication abilities for direct interfacing with hospital information systems.
Coeliac disease affects 1 in 100 genetically predisposed individuals who develop a small intestinal inflammation on exposure to dietary gluten. Symptoms can include bloating, abdominal pain, nausea, constipation, diarrhea, wind, tiredness, anemia, headaches, mouth ulcers, recurrent miscarriages, weight loss, skin problems, depression, joint or bone pain and nerve problems. The only treatment is the lifelong avoidance of ingestion of gluten.
Delay of 11.7 years from symptoms to diagnosis
Due to the wide variety of the symptoms of the disease, not only do CD patients suffer from a reduced quality of life during the years they pass undiagnosed – the average delay from onset of symptoms to diagnosis being 11.7 years, but they are also unnecessarily hospitalized and quite often completely misdiagnosed, and treated with costly drugs. There are serious problems associated with untreated CD including osteoporosis, infertility, certain kinds of gut cancer and increased risk of other autoimmune diseases. Early diagnosis and strict maintenance of a gluten-free diet will significantly reduce the risk of problems associated with CD.
Population screening is the only way to identify the majority of CD patients. Serology-only tests are not sufficient, as false negatives are often encountered. HLA-typing alone can also show false positives, as it can also point to subjects who eventually may not develop coeliac disease. A combination of serology and HLA-typing is the only definitive way to screen for CD; a combined diagnosis accounting for symptomatic, silent and latent CD patients aims for a 100% specificity and sensitivity.
Lab-on-a-chip device to support early diagnosis in primary care
An easy-to-use point of care test for use in the primary care setting will provide better opportunities for early diagnosis and allow periodic monitoring of the patient’s compliance with a gluten-free diet. Additionally an eventual version of the device could find application in home monitoring where a GP could follow a patients reaction to withdrawal of gluten from the diet and compliance with the gluten free diet by monitoring the autoantibody levels.
CD-MEDICS is bringing innovation and bio-, micro- and nanotechnologies to respond to these demands.
A core component of the later diagnosis system is a so called lab-on-a-chip disposable. This credit card sized lab enables the user to directly put a drop of blood in the lab-on-a-chip device, insert this device in the respective instrument and run the diagnostic test without any further actions besides pushing the start button. The lab-on-a-chip device looks like a simple piece of plastic but incorporates comprehensive intelligence: in a first instance a microstructured fluidic network allowing for a precisely controlled flow of reagents, secondly a specially adapted surface for capturing the biological components being looked for, and finally an electrically driven sensor system to enable an integrated and extremely fast detection.
The CD MEDICS project also aims at building point-of-care diagnostic devices that are capable of seamlessly operating in all point-of-care-driven environments (e.g. clinical laboratories, hospitals, physicians’ offices and patient-self-testing at home or mobile) 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 – such as age, age, gender, main diagnoses and therapies - resulting in better analysis and interpretation of the measured results.
The rapid dissemination of the innovative screening technology as well as an increase in awareness of CD amongst primary health workers is required to gain the utmost advantage from the screening method. CD-Medics thus has a whole workpackage dedicated to dissemination and it is planned that this shall be achieved through the identification of synergies and collaborative activities with other CD related research. A series of roadshows will be organised to obtain the necessary feedback from other researchers and end users as well as participation in conferences, trade fairs and publications.
###
Source: HealthTech Wire for CD-Medics
