Point-of-Care Chemiluminescent Diagnostic for 'early detection'of the predisposition to Type 2 diabetes.

Chemically induced light emission technology is being coupled to engineered nanoscale structures to create a unique type of sensor which is so sensitive and so specific that it will be able to measure extremely low levels of disease markers in a blood sample. The molecules of interest for a proof of concept demostrator are those associated with Type 2 diabetes. The point-of-care diagnostic will allow a member of the public to determine whether they are likely to develop Type 2 Diabetic within the next 5 years of life. The user would be able to do this at home, at a pharmacist or under the supevision of their doctor.

The key to the technology is the nanostructure and composition of a biosensing patch which can be produced in extremely large numbers at low cost by combining scale up techniques to make large sheets of the nanoscale material with extremely fast laser cutting processes which are able to cut channels which are only 10 micrometers wide.

The technology has the potential to be configured to measure panels of disease markers within a single blood spot sample, which has the potential to measure the severity of disease and determine how far the disease has progressed.

The high sensitivity and specificity of the diagnostic will allow early diagnososis of disease, which will lead to improved patient outcomes.

Other applications include environmental and food monitoring and anti-counterfeit.

The global population will be beneficiaries of the diagnostic due to increased numbers enjoying life long health and well being. Directly by delaying the onset of Type 2 diabetes by changing lifestyle and diet and increasing exercise. Indirectly, due to an increased expenditure directed towards treating other diseases due to the savings made by reducing the prevalence of Type 2. For example if widespread home screening for the predisposition of Type 2 resulted in the prevalence of Type 2 in the Uk being reduced by 10%. This would be a saving to the NHS of approximately £1Billion per annum. These savings could be passed on or redirected to treat other diseases. With modest investment and exploitation of existing supply chains and technical resources the impact could be realised within 3 to 5 years.

The project aims to bring the performance of laboratory based chemiluminecent assays to the point-of-care and home user setting. Type 2 diabetes is the focus of our Proof-of-Concept demonstartor, but the technology can be translated to other disease types, including HIV, Alzheimers, and Cardiac.

We have identified a UK supply chain with capabilities suitable to manufacture, distribute and market the diagnostic device. (see Pathways to Impact document). It is expected that these companies will benefit due to increased turnover and profit.

Global health care providers would be users of the platform technology, whether during the diagnosis of disease or as a companion diagnostic for selecting effective phamaceutricals by stratifying patients.

We have received interest from Biocell International an Alere company which is the worlds leading point of care diagnostic company. GE Lifesciences have identified opportunities for a prescreening diagnostic for PET imaging. We believe Big Pharma would be interested in companion diagnostics which have extremely high sensitivity and selectivity, since this could provide opportunities to capitalise on their clinical assets which have failed trials due to non-stratified patient groups during clinical trials.

Outside human healthcare, the diagnostic could be used for veterinary science, anti-counterfeit, and environmental monitoring.

We have won funds from NISCHR (National institute for Social Care and Health Research) which is a department of the Welsh government. They have peer reviewed the technology and funded £42k towards the work to be undertaken by Cardiff University. NISCHR are in a position to inform government of new technologies with economic and societal and environmental impact.

Staff working on the project will develop skills to create novel materials by electrospinning and develop network links to a range of device manufacturers and highly technical process providers.