TNO discovers new method to diagnose liver disease

Functional Biomarkers Signatures
3 June 2024

TNO, in collaboration with Academic Medical Centres of Amsterdam, Leiden, and Copenhagen, has discovered a new set of biomarkers* that can be measured in the blood and can determine the degree of fibrosis – the formation of scar tissue in the liver. Liver fibrosis is currently diagnosed by taking a liver biopsy (a sample from the liver). Diagnosis using blood biomarkers spares patients an expensive and painful procedure that is not without risk.

Nature Communications published a paper by TNO researchers on the newly discovered method, in which measuring 3 specific proteins is enough to determine the severity of the fibrosis.

Number of people with fatty liver disease on the rise

The growing number of overweight people also means that the number of individuals with fatty liver disease (metabolic dysfunction-associated steatotic liver disease (MASLD)), is increasing very rapidly, including additional complications such as fibrosis.

Currently, the extent of liver fibrosis can only be determined with certainty by taking a liver biopsy. This is a painful and expensive procedure that is not without risk. For this reason, there is a need for quick ways of determining the extent of liver fibrosis that are cheaper and less stressful for patients.

Better insight into the stage of the condition

TNO used a previously developed laboratory animal model that very accurately mimics the disease in the patient. That made it possible to study the dynamics of the disease and gain insight into the proteins that play a role in it. Additionally we examined which of these proteins are also present in patients' blood and can be measured there.

This led to a set of three proteins (biomarkers) that a) are simple to measure, b) can distinguish well between the various grades of fibrosis, and c) have a better predictive value than biomarkers that are currently regularly measured. This unique set of biomarkers was subsequently validated in an independent Danish patient cohort.

As part of the current collaborative study, it will also be evaluated whether the set can contribute to ongoing Dutch and international care pathway studies for MASLD-MASH and thus ultimately to the Dutch MASLD-MASH guideline. It therefore looks as if these biomarkers will be of great added value, not only in diagnosing liver fibrosis, but also in selecting patients for clinical MASLD trials or in being able to monitor the effect of treatments at an early stage.

Clinical preliminary examination can be more focused

To demonstrate the effectiveness of a drug, pharmaceutical companies need to conduct clinical preliminary studies. For this, it is essential that the right patients participate. Clinical research centres, where these studies are conducted, therefore benefit from using the TNO biomarker set because it allows faster and more accurate identification of eligible and ineligible patients. Ultimately, it is the patient who in this way can gain faster access to an effective drug.

Effect of treatment can be monitored early on

Because the biomarkers are linked to the active disease mechanism, TNO expects they can also be used to quickly determine whether or not a therapy is effective.

With the biomarkers now discovered, this can be seen much sooner after the start of treatment. Further research is needed on this. But it would ultimately be an improvement towards a less stressful, more effective, and cheaper treatment for the rapidly increasing number of patients with liver fibrosis.

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