Precision Healthcare - A novel diagnostic handheld platform for the detection of cancer biomarkers in urine

Cancer is the leading cause of death in developed countries and there is a major desire to pivot towards preventative rather than curative based medicine. Currently, effective treatment heavily relies on early stage detection and an accurate diagnosis of the cancer through molecular profiling. Liver cancer is the third most common cause of death due to cancer and has a global incidence of 1 million new cases annually. The prognosis for patients is poor and even worse in resource-poor settings such as sub-Saharan Africa, and Central and Far-East Asia. For example, liver cancer, linked to hepatitis B infection, currently kills nearly four times as many people as HIV/AIDS in Africa, however early detection could have a significant impact on survival rates. In both the developed and developing world, there is a critical need for new tools and technology for the routine detection and diagnosis of cancer and diseases in general.

The goal of this project is to develop a handheld device that can detect biomarkers in urine that will be able to diagnose liver cancer at the point-of-care. It will be assessed using validated patient urine samples. The technology upon which this is based is high performance liquid chromatography (HPLC). Like how a glass prism separates white light into its component colours, HPLC separates a liquid into its component analytes. HPLC is a gold standard analytical technique crucial to many industries worldwide in its ability to separate and identify chemicals in a complex mixture. HPLC is ideally suited to detecting and quantifying biomarkers in urine; however, it is not currently portable or suited to point-of-care analyses due to its size, cost and complexity. As part of this project, we will miniaturise the technology to a handheld device. Point-of-care or on-site HPLC analysis would provide results that could be acted on within minutes that otherwise would take weeks.

Due to the crisis in healthcare provision, such technology would ideally be suited to monitoring any individual, not only patients, in the home in order to realise the vision of next generation precision healthcare. Such a device has the potential to monitor us on a daily basis and act as an early warning system for doctors. Such person-specific molecular data may be used to detect or even predict the onset of disease."

A diagnostic urine test for liver cancer represents a major step forward in cancer screening. However, detection of these biomarkers requires instrumentation currently restricted to centralised laboratories due to their size, complexity and cost. This fellowship aims to address these obstacles which prevents the widespread and routine adoption of such precision diagnostics. We aim to develop and validate a handheld device for the detection of liver cancer biomarkers in urine, based on high performance liquid chromatography (HPLC). A diagnostic urine test for liver cancer at the point-of-care would provide a practical and cost effective solution to detect this disease early and improve survival.

Benefit to Society
Cancer is the one of the leading causes of death worldwide, particularly in developing countries. One in three women and one in two men will be diagnosed with cancer in their lifetime. Through public awareness and screening programmes, significant improvements have been made over the last few decades. More advanced diagnostic techniques hold significant potential in diagnosing disease early and saving lives. The project coordinates the expertise of clinicians, analytical technology development and industry to focus efforts toward ultimately benefiting patients. The project has the potential to offer in-field cancer screening in low and middle income countries and detect liver cancer at an early stage when the tumours are still treatable. The development of lightweight, field-portable quantitative detection methods will allow the introduction of a range of screening programmes and disease monitoring in areas which have previously not had access to such schemes, providing rapid and precise information to medics in both routine treatment and emergency relief work.

Benefit to the economy.
The potential for personalised medicine and molecular diagnostics to transform clinical practice has been well documented. The global personalised medicine market is expected to reach $233 billion by 2025 and is growing over 9% annually. The growth of new technologies and the rising use of biomarkers for diagnosis are major trends in the market. The outputs of this award will be the achievement of a handheld diagnostic for urinary cancer biomarkers supported by experimental data and a physical prototype. This is a crucial step to achieving our aim of improving access to healthcare and will place the project in an advantageous position for commercialisation. The broad applicability of HPLC in analytical chemistry means that the physical outputs of this project will have many applications in a broad range of environmental monitoring and agricultural applications, from identifying and responding to chemical spills and industrial contamination to optimising fertiliser and pesticide application and crop residues in agriculture. It is therefore important to initiate discussions with key industrial partners in these sectors.

Benefit to People
The award of the fellowship will allow me to continue my programme of research and the supervision of Ph.D., MRes and MSci/BSc students as well as provide training and skill development to the PDRA. The technical and analytical advances that will arise from this proposal will be of interest to the analytical and healthcare scientific communities and will be disseminated through publications and conference presentations. I have significant experience in public engagement and the topics here will form part of any future outreach. A Twitter account is already in place to disseminate my results and publicise events relevant for a broad audience.