The University of Southampton
Medicine

Developing a non-invasive test for fibrosis severity in chronic liver disease

University of Southampton research into the development of biomarkers to predict fibrosis severity in chronic liver disease (CLD) has resulted in the development of a non-invasive test. With industry collaboration this test has been validated, CE marked, standardised and launched in the NHS. It is now available for use by clinicians throughout Europe and is only one of two CE-marked biomarker panels currently available in England.

Overview

Research Challenge

Liver fibrosis is the common response of the liver to any injury and is largely asymptomatic until the final stages of disease. Early identification of patients with significant liver fibrosis, in whom interventions can be utilised to reduce morbidity and mortality, is vital.

Context

There is currently a rising epidemic of patients with obesity and hazardous drinking habits, both risk factors for CLD. The ability to use a simple blood test to accurately identify those with significant liver disease will greatly aid triage and the effective targeting of interventions including weight loss, exercise and prescribed drugs.

Our Solution

Our team’s early laboratory research investigated the biology of the cell which plays a central role in fibrosis in the liver. We then identified and characterised potential components for use as biomarkers in clinical situations.

Over 1000 patients were recruited to validate a biomarker panel that could predict fibrosis severity on biopsy. A panel of three markers termed the ‘enhanced liver fibrosis test’ (ELF) showed excellent performance in patients with CLD.

The test was validated in patients with single aetiology liver disease and a follow up study showed it to perform well in predicting fibrosis on biopsy and clinical outcomes.

What was the impact?

Our research on biomarkers and non-invasive tests in CLD has been highlighted in the Department of Health.


In 2011 the ELF test became widely available for use in clinical practice and has changed the way patients are managed. The test also improves early evaluation of CLD patients and can be used to prioritise investigations and determine the severity of fibrosis without a biopsy.

Knowledge of fibrosis severity, progression or regression is highly valuable to patient and doctor. ELF makes this information accessible through a simple blood test that can be repeated at frequent intervals.

Laboratory researcher working on non-invasive test for liver fibrosis
Tool to detect liver fibrosis

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