Novel biomarkers for non-alcoholic fatty liver disease

Academics at Oxford have identified new biomarkers for non-alcoholic fatty liver disease (NAFLD) which affects on average 1 in 5 people worldwide.

These markers were found to be promising in comparison to other test biomarkers and they would enable a new diagnostic test to be developed to reduce the need for invasive liver biopsies. The methods that are under development include the first antibody-free serum protein biomarker assay for NAFLD and the first ever rapid point of care test (POCT) which could read the most informative biomarkers from a single drop of finger-pricked capillary blood. The technology aims to be less invasive than a liver biopsy and capable of stratifying patients according to the stage of NAFLD, ensuring treatment can be effective and disease progression can be reduced.

Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of progressive liver disease ranging from non-alcoholic fatty liver (NAFL) to non-alcoholic steatohepatitis (NASH). Approximately 1 in 3 people in the US and the UK have some degree of NAFLD and the disease is strongly associated with obesity.

Both hepatic fibrosis and cirrhosis can be seen in NAFLD patients. It is imperative to diagnose fibrosis in the early stages of reversible liver scarring so that irreversible liver damage in cirrhosis can be prevented. Cirrhosis is the cause of over 6,000 deaths every year in the UK, and approximately 27,000 in the USA, making it the ninth leading cause of death.

Currently, the reference standard for assessing liver fibrosis and NAFLD is the liver biopsy, an invasive, painful procedure which can be unreliable, costly and can have a false negative rate as high as 20%. Consequently, there is a need for improved, minimally-invasive methods of determining stages of NAFLD in patients.

Assessment and diagnosis of patients with NAFLD

Academics at the University of Oxford have now identified protein biomarkers that are either up- or down-regulated in patients who are at different stages of lobular inflammation and fibrosis/cirrhosis as well as differentiating NAFL and NASH. By quantifying the biomarkers in a biological sample, the technology could potentially be used to diagnose, prognose or monitor the progression of NAFLD in an individual.

To utilise these new biomarkers effectively, the academics have developed the first antibody-free serum protein biomarker assay for NAFLD which, unlike currently used immunoassays, has the potential to detect degraded proteins. They are also developing a rapid point of care test (POCT) which can determine biomarker levels from a single drop of finger-pricked capillary blood. These methods are rapid, less invasive and can be performed easily on all patients. They may also stratify patients according to the stage of NAFLD, ensuring treatment can be effective and disease progression can be reduced.

Commercialisation

This technology is at the preclinical stage and will need to be validated in larger clinical cohorts. This technology is subject to a patent application and we are looking for commercial partners who wish to collaborate with us to validate the biomarkers or licence this technology.

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