Novel Point-of-Care Diagnostic Techniques for Dementia

The aim of this proposal is to create a new way, using multiplex graphene-based biosensors, for the detection of biomarkers found in biological fluids (e.g. blood, CSF, urine and saliva)
in the early stages of dementia (with emphasis on Alzheimer's disease) and changes in levels with disease progression.

A generic, Point-of-Care (POC) biosensor technology, based on graphene transducers, has already been developed by one of the project partners and demonstrated for
the detection of several disease biomarkers. Unlike existing analytical approaches, the sensor is a rapid diagnostic platform, yielding real-time data and a conclusive test
result within minutes of the sample being taken. The idea is to combine this with novel electronic multiplex techniques and large area graphene to create a multiplexed
biosensor array technology to enable the detection of multiple biomarkers of dementia simultaneously with the potential to significantly increase throughput.
An objective of the project is to demonstrate a novel, low-cost, reliable, POC diagnostic platform, based on multiplex graphene biosensors, for early detection of
dementia and following its progression from biological fluid such as blood.

The development of a low cost, point-of-care biosensing technology that makes it possible to detect dementia, objectively, in the early stages and to
monitor disease progression, rapidly, from a simple blood test would revolutionise diagnosis of dementia and have a huge positive impact on the selection of
subjects for clinical trials for new drugs and for monitoring response to treatment.

The diagnostics device sector has experienced a strong growth over the past ten years, with significant commercial deals in 2013, especially in the USA. It is crucial that the development of detection and progression monitoring technology proceeds in parallel with clinical research if the UK is to remain a strong player in the area of dementia. SU and PU have both been working on Graphene technology for biosensing applications and independently developed background IP and complimentary expertise to capitalise on.
PATIENT BENEFITS: This project will create a technology with the potential to revolutionise the way we currently diagnose dementia. Instead of relying on expensive laboratory-based tools and assays, diagnosis could be carried out at point of care (POC). The high sensitivity of the devices could enable early detection and much closer monitoring of disease progression, leading to improved clinical decisions and health outcomes for patients. In addition, it will be possible to routinely carry out diagnosis for more people. Since POC diagnostics encompass hospitals and homes, the barriers to obtain an initial diagnosis will be greatly reduced as well as number of people who do not get a diagnosis at present.
INDUSTRIAL IMPACT: Graphene technology has so far eluded real commercial applications. This project will help to finally close the gap with a real world application with true commercial impact in the healthcare sector. As we will demonstrate a novel, sensitive and specific multiplex diagnostic POC platform for the detection of multiple dementia biomarkers in blood, the key breakthroughs required to achieve this platform are novel graphene FETs and FET arrays on large area graphene combined with innovative multiplex functionalization processes and manufacturing. These electronically addressable sensors will be developed and demonstrated in pre-clinical studies. The project will lead to the development of further IP around functionalisation, integration, fabrication and detection technologies for Dementia detection and disease progression monitoring. This will consolidate the partners' position in the commercial space and enable the development of potential joint business opportunities in the diagnostics industrial sector, which is seen by UK government as an area of strength and critically important to be maintained. We expect a Joint Venture (JV) to be set-up within 18 months from the start of the project. This JV will likely see the involvement of all partners and will exploit the developed IP. At this point, we see the real value generation to be in the new IP created and in the demonstration of a reliable technology platform. The creation of a real-world diagnostics platform based on graphene will in turn greatly de-risk the entire graphene-based technology area, therefore opening up a wide variety of applications which, at the moment, remain purely at prototype stage, at best. The technological outputs from the project have real potential to create a new market, that of routine checks and monitoring, at the POC, using more economical devices. This model essentially resembles the "Gillette model" applied to diagnostics.
ACADEMIC IMPACT: The project will also have significant academic impact. The creation of an innovative, more accurate and cost effective diagnostic technologies for early diagnosis of dementia and monitoring disease progression will create the basis for an objective way to bench mark patient outcome in research in dementia. In summary, the benefits are enormous: PoC early detection and monitoring technology for dementia will greatly benefit patients enabling easier diagnosis and reduced costs to the NHS; commercial application will enhance UK leadership in graphene technology and POC healthcare diagnostics. Commercial impact will also include the entire value chain, from engineering design through to high value manufacturing, all of which will directly benefit the economy.