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Position Paper: Early Diagnosis Ambitions for the UK

Introduction
Early detection and diagnosis of illness saves lives. If diagnosed at the earliest stage, almost all women with breast cancer, and more than nine in ten people with bowel cancer, survive their disease for five years or more. This falls to around three in ten women when breast cancer is diagnosed at the most advanced stage and drops to just one in ten people for those with bowel cancer.

The advent of new therapies for Alzheimer’s disease marks a turning point in managing progression of the disease. Early and accurate diagnosis - aided by the discovery of new novel biomarkers and advances in brain imaging technology - will be key to identify those who will benefit most from these treatments.

Access to Personalised Treatment Strategies
As treatment strategies become increasingly personalised, the systematic utilisation of diagnostic information from, amongst others, genetic tests, novel biomarker assays, broader elements of patient health data and advances in medical imaging is critical to inform tailored treatment strategies and decisions.

  • ASK The genomic medicine service across the UK must widen access to genomic testing and reduce variability so that it is a standard diagnostic test across more clinical pathways.

Early Detection Research
Significant progress has been made in the identification of biomarkers and matched therapies in oncology, with around 55% of all oncology clinical trials in 2018 involving the use of biomarkers, compared with around 15% in 2000. Yet, early detection research is still a comparatively new and fragmented field with substantial barriers because of, for example, complex and unclear biology, a paucity of longitudinal and linked data sets, and complicated navigation of unclear regulatory and approval pathways. A multidisciplinary and multisectoral network is needed spanning academic research, industry, research funders, regulators, investors, healthcare professionals, NHS decision makers, government, and, crucially, patients and the public.

Many of these issues were picked-up by Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK. The UK Government has since pledged to fully implement the five headline commitments in the review, and to make progress against all the problem statements identified.

Further areas for consideration include:

  • ASK Stronger links must be made across genomic and clinical datasets to understand how genomic alterations drive patient outcomes.
  • ASK Investment is needed in a national data research infrastructure that enables access to the full scale, depth and diversity of UK health data with a streamlined governance system that preserves privacy and data security, and with commercial terms that are globally competitive.

Screening and Risk-Based Prevention
Early detection also shows potential in minimising risk to disease in the first place. As the amount of data generated from an individual’s healthcare journey increases, the application of AI tools enables the incorporation and computational analysis of disparate, complex data streams - genomic, clinical, behavioural - rendering possible a route to risk-based detection and prevention.

Screening through the identification of new disease biomarkers, and then developing tests to detect those, has the potential to increase the chance of finding individuals who do not exhibit symptoms of disease, but may have an increased risk of a particular condition. For instance, there is currently no screening programme for prostate cancer, the most common cancer in men in the UK, because the prostate specific antigen (PSA) blood test, which is usually the first step towards a diagnosis, is not nearly accurate enough to be used as a primary screening test. The TRANSFORM trial seeks to find the best way to screen for prostate cancer.

The use of the faecal immunochemical test (FIT) to detect bowel cancer is expanding as new evidence highlights its effectiveness. It is being made available to everyone aged 50 to 59 years and as the primary diagnostic tool. It is raising patient outcomes as early detection leads to faster curative surgical treatment.

  • ASK The UK National Screening Committee, jointly with partners, should commission more research as well as reviews of updated evidence for conditions where diagnosis rates are low or late.
  • ASK As the application of AI in healthcare gains momentum, regulatory frameworks must be developed that enhances patient safety, protects patient access and attracts innovation, including the recognition of the approvals of HealthTech from trusted international jurisdictions such as the US and EU.

Early Diagnosis Industry
Beyond the clear potential for health benefits, a shift to early diagnosis can alleviate the need for costly, long-term treatments, thus aiding the clinical workforce and easing pressures on the healthcare system itself. The UK can be a world leader in developing a thriving early detection and diagnosis industry, capitalising on its excellent science base, the unmatched diversity of health data and infrastructure and a history of collaborative efforts across an interlinked network of expertise.

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