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

Lead Research Organisation: Nottingham Trent University
Department Name: School of Science & Technology

Abstract

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.

Planned Impact

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 assetswhich 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.

Publications

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Description The use of nanomaterials as a solid phase support for diagnostic devices
Exploitation Route New point of care diagnostics
Sectors Aerospace, Defence and Marine,Agriculture, Food and Drink,Chemicals,Environment,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

 
Description The outcomes of the research have been used as evidence to support a grant application into the STFC miniIPS programme to develop the point of care devices for early warning of the onset of type 2 diabetes. Also a bid has been submitted to the Wellcome Trust to develop a new would healing diagnostic
 
Description STFC mini IPS
Amount £82,663 (GBP)
Funding ID ST/M004244/1 
Organisation Science and Technologies Facilities Council (STFC) 
Sector Academic/University
Country United Kingdom
Start 04/2015 
End 03/2016
 
Title Electrospinning System 
Description Self built electrospinning system for the production of non-woven and aligned nanofibre materials. Supported by additional funding from Nottingham trent University 
Type Of Material Improvements to research infrastructure 
Year Produced 2013 
Provided To Others? Yes  
Impact Eleectrospun materials being investigated for novel Solar Sterilisation Techynology for clean safe water 
URL http://www.ntu.ac.uk\iSMART
 
Description Cardiff University, School of Medicine 
Organisation Cardiff University
Department School of Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Collaborative Research between the Material Science capability at iSMART, School of Science and Technology at Nottingham Trent University and the Department of Biochemistry at Cardiff Medical school.
Collaborator Contribution Development of Chemiluminescent protocols
Impact Multi disciplinary. Development of Nanofibe materials and associated processing technology. Protocols to label nanofibre materials with Chemiluminescent probes
Start Year 2012
 
Description Chemiluminescent probes 
Organisation Invitron
Country United Kingdom 
Sector Private 
PI Contribution Development and fabrication of nanofibre materials
Collaborator Contribution Supply of chemiluminescent probes
Impact Proof of concept has been achieved for a new Point of Care diagnostic
Start Year 2012
 
Description Diagnostic well plate assembly 
Organisation Porvair Filtration Group Ltd
Country United Kingdom 
Sector Private 
PI Contribution Development of a nanofibre coating process which is compatible with plastic welding
Collaborator Contribution Ultrasonic welding of well plate bases to well plate trays.
Impact Participation in a follow on project.
Start Year 2012
 
Description Nanofibre deposition 
Organisation Nano Products
Country United Kingdom 
Sector Private 
PI Contribution Deposition of nanofibre mats onto perforated flexible substrate materials
Collaborator Contribution Supply of bespoke substrate materials
Impact Follow on grant applications to STFC
Start Year 2011
 
Description Team to commercialise POC diagnostic 
Organisation Invitron
Country United Kingdom 
Sector Private 
PI Contribution Electrospinning of Nanofibre materials
Collaborator Contribution Conversion to suitable structures. Manufacture of probes
Impact Prrof of Concept
Start Year 2011
 
Description Team to commercialise POC diagnostic 
Organisation Nano Products
Country United Kingdom 
Sector Private 
PI Contribution Electrospinning of Nanofibre materials
Collaborator Contribution Conversion to suitable structures. Manufacture of probes
Impact Prrof of Concept
Start Year 2011
 
Description Meeting to discuss Innovate UK Health and Life Sciences proposal 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Industry/Business
Results and Impact Discussion to determine whether project proposal is in Scope to call
Year(s) Of Engagement Activity 2017