(London, UK) 20 August 2024. Predictive Health Intelligence’s flagship product, hepatoSIGHT, a case-finding search engine that enables clinicians to identify people potentially at risk for liver disease, has now received Class I clearance from the Medicines and Healthcare products Regulatory Agency (MHRA).
Liver disease is a huge public health burden in the UK, claiming over 10,000 lives every year [1] and is the second leading cause of premature death in the country. It’s also the only major non-communicable disease where death rates are rising [2, 3].
The late detection of chronic liver disease increases the chance of complications such as liver cancer, liver failure and therefore the need for transplants. In the UK, liver cancer has the largest annual percentage increase for incidence and the highest average annual increase in mortality for people aged between 35 and 69 years [4]. The problem is that chronic liver disease is challenging to diagnose early. It often has no symptoms until a late stage, when treatments are limited and when care places a larger burden on the health system.
To address this problem, Predictive Health Intelligence, a unique part-NHS-owned enterprise, has developed hepatoSIGHT, a groundbreaking case-finding tool designed to harness the vast amounts of historical medical data that has been built up over decades. By systematically scanning blood records, the tool enables clinicians to identify patients that are at higher risk of developing liver disease, offering healthcare providers a powerful new way to spot the disease earlier in its pathway.
Now, hepatoSIGHT has received Class I medical device clearance, which means it is available for clinical use across the UK, paving the way for millions of people to benefit from this innovative technology.
“This is the culmination of five years of hard work,” says Dr. Tim Jobson, consultant NHS gastroenterologist and co-founder of Predictive Health Intelligence. “The development of hepatoSIGHT was driven by my frustration at seeing patients diagnosed with liver disease when it was already too late for most treatments. Our hope is that the tool can prevent people from falling into that situation.”
The development and testing of hepatoSIGHT were made possible through a grant from the National Institute for Health and Care Research (NIHR) and included a collaboration with expert health IT company Stalis. As part of a service improvement project with partners at NHS Somerset Foundation Trust, the tool helped doctors identify hundreds of individuals who could benefit from further investigation of their liver health. As a result, dozens of these patients are now receiving treatment and monitoring to prevent their liver disease from progressing. The conditions identified so far include primary biliary cholangitis (PBC), viral hepatitis, metabolic-associated liver disease, and undiagnosed cirrhosis.
The recent Class I clearance of hepatoSIGHT exemplifies the mission of NIHR funding: to enable the testing, development, and deployment of innovative ideas that have the potential to benefit the entire nation.
Professor Mike Lewis, NIHR Scientific Director for Innovation, said: “Clearance of this technology will enable finding of cases of liver abnormalities earlier than previously possible and hopefully before they become life altering. This project is a clear example of how the NIHR through the i4i programme helps fund innovations and research that has real impact.”
Looking ahead, Predictive Health Intelligence is already in discussions about further deployments of hepatoSIGHT, with plans to extend its coverage to a population of approximately 10 million people in the near future.
ENDS
- https://www.gov.uk/government/statistics/liver-disease-profiles-march-2023-update/liver-disease-profiles-march-2023-update
- Williams R, Aspinall R, Bellis M, et al. Addressing liver disease in the UK: a blueprint for attaining excellence in health care and reducing premature mortality from lifestyle issues of excess consumption of alcohol, obesity, and viral hepatitis. Lancet 2014
- Liver disease profiles, March 2023 update. Office for Health Improvement and Disparities. https://www.gov.uk/government/statistics/liver-disease-profiles-march-2023-update/liver-disease-profiles-march-2023-update
- 25 year trends in cancer incidence and mortality among adults aged 35-69 years in the UK, 1993-2018: retrospective secondary analysis doi:10.1136/bmj-2023-076962
About Predictive Health Intelligence
About the National Institute for Health and Care Research
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. They do this by: Funding high quality, timely research that benefits the NHS, public health and social care; Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services; Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research; Attracting, training and supporting the best researchers to tackle complex health and social care challenges; Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system; Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government.
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