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A pioneering European research project aims to lead to new diagnostic tests to assess patients with non-alcoholic fatty liver disease (NAFLD) and identify those most at risk for developing severe inflammation and liver scarring. Researchers from the Oxford Centre for Clinical Magnetic Resonance Research will play a key role in evaluating a series of biomarkers for NAFLD.

Litmus liver scans 1 Perspectum
Examples of MRI scans, processed with LiverMultiScan™, from patients with mild NAFLD (left) and significant NAFLD (right)

Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) funded by the European Innovative Medicines Initiative 2 Joint Undertaking, brings together clinicians and scientists from prominent academic centres across Europe with companies from the European Federation of Pharmaceutical Industries and Associations (EFPIA). Their common goals are developing, validating and qualifying better biomarkers for testing NAFLD.

The €34 million project is co-ordinated by Newcastle University, working closely with the lead EFPIA partner, Pfizer Ltd. LITMUS will include 47 international research partners based at leading international universities and some of the world’s largest pharmaceutical companies.

NAFLD affects 20-30% of the population and is caused by a build-up of fat in the liver cells, leading to inflammation, scarring of the liver and ultimately cirrhosis. It is strongly linked to obesity and type 2 diabetes.

Although many people have NAFLD, less than one in 10 will come to harm as a result. The challenge is to identify those people that will be most severely affected and are going to progress to liver cirrhosis or cancer so that appropriate care can be provided earlier. At present this requires a liver biopsy, which can only be done in specialist hospitals, so there is a need for better diagnostic tools.

The team in Oxford, led by Prof Stefan Neubauer and Prof Stephen Harrison, will lead the work on the evaluation of a suite of imaging biomarkers – including novel techniques developed in OCMR and by the university spinout company Perspectum Diagnostics – to assess patients with NAFLD and identify those most at risk of disease progression.    

Professor Quentin Anstee, from Newcastle University’s Institute of Cellular Medicine and Consultant Hepatologist at Newcastle Hospitals NHS Foundation Trust, is co-ordinating the LITMUS consortium.

He said: “Non-alcoholic fatty liver disease is already the most common underlying cause of liver transplant in the USA and, with the obesity epidemic in Europe, we are very close behind.

“LITMUS will unite clinicians and academic experts from centres across Europe with scientists from the leading pharmaceutical companies, all working together to develop and validate new highly-accurate blood tests and imaging techniques that can diagnose the severity of liver disease, predict how each patient’s disease will progress and monitor those changes, better or worse, as they occur.

“Lack of easy and accurate diagnostic tests means that many patients go undiagnosed until late in the disease process. It has also held-back efforts to develop new medical treatments for NAFLD. Availability of better diagnostic tests will help us to target care at an early stage of disease to the people who are going to be most severely affected. It will also help us to develop more effective medical treatments for NAFLD and to run the clinical trials that the regulatory agencies need so that they can licence these medicines to be prescribed by doctors.”

Prof Stefan Neubauer, Professor of Cardiovascular Medicine, is Director of the Oxford Centre for Clinical Magnetic Resonance Research. Discussing the project he said:

‘We are looking forward to using expertise in Oxford to help tackle a major unmet clinical need. We have developed new magnetic resonance imaging approaches to assess liver scarring and inflammation, and we will evaluate these techniques and others for how effectively they allow clinicians to diagnose NAFLD, predict disease progression and measure response to treatment.’

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