Cambridge-based Owlstone Medical has announced new results from a study of its breath-based diagnostic test for liver disease, including Nonalcoholic Fatty Liver Disease (NAFLD) and associated Nonalcoholic steatohepatitis (NASH).
The study investigated the use of exhaled limonene as a breath biomarker to measure liver function and stage liver disease in 32 cirrhosis and 12 cirrhotic hepatocellular-carcinoma patients, compared with 40 in the control group.
The breath samples from each group were analysed by Owlstone’s breath biopsy platform, resulting in positive results (73% sensitivity and 77% specificity) demonstrating the efficacy of using limonene levels to find alterations in liver function.
According to Owlstone, these results have promise, showing that limonene could be used as a marker of liver metabolic capacity.
“This study represents a major milestone for Owlstone Medical, as it is the first proof of the value of our EVOC probe approach for the development of breath tests in areas of high clinical need,” said Billy Boyle, co-founder and chief executive officer at Owlstone.
“Much like how PET scans work, this involves the introduction of a compound to the body that elicits a strong and clearly readable signal over background.
“We have identified a number of additional highly promising compounds that we are working to validate as EVOC probes for liver disease and we believe our EVOC probe approach can be applied to other disease areas, including lung cancer, where earlier and improved diagnosis is clearly needed to save lives,” he added.
Owlstone is currently developing a number of non-invasive quantitative breath tests that use its proprietary EVOC Probes, including limonene along with inflammatory exhaled biomarkers, to measure liver enzyme activity and provide information on the health of the liver and for NAFLD/NASH diagnosis and prognosis.