Owlstone Medical has presented new data showing the progress being made in the development of breath biopsy tests for liver cirrhosis and non-alcoholic steatohepatitis (NASH) at the EASL Congress 2023.
Dynamic Limonene Breath Testing Maximizes Classification Performance for Subjects with Cirrhosis describes Owlstone Medical’s research efforts to establish limonene as a non-invasive EVOC probe for liver disease through a cross-sectional study run at the Facultad de Medicina Clínica Alemana Universidad del Desarrollo and Hospital Padre Hurtado, Santiago, Chile.
The study used 29 ultrasound-confirmed cirrhosis cases and 29 healthy controls to determine the performance of Owlstone Medical’s limonene breath test for detecting cirrhosis. It explored the optimal time for collecting breath samples after ingestion of the EVOC probe, and the correlation between limonene availability and the severity of the disease.
It determined that optimal test performance was seen at 60 minutes post-administration. Additionally, the study results closely correlated with disease severity, opening up the use of the approach for early disease detection.
Dr Luis Méndez Alcaman, primary investigator, Facultad de Medicina Clínica Alemana Universidad del Desarrollo and Hospital Padre Hurtado, said: “Through this study, we have demonstrated that altered levels of limonene in exhaled breath following ingestion of an EVOC probe can effectively identify subjects with cirrhosis compared to controls. Notably, most of the patients in the study were early-stage cirrhosis cases and not decompensated, adding validity to our reported conclusions.
“The exciting potential value of Owlstone’s approach was reinforced during the study through two clinical cases that had been misallocated through initial ultrasound scans but were correctly identified by the breath test, one healthy control that actually had cirrhosis, and one cirrhotic patient whose disease had resolved.”
The study results serve as proof of principle towards the goal of deploying tests for liver cirrhosis and NASH. They were presented in a poster at the annual meeting of the European Association for Study of the Liver, taking place June 21-24 in Vienna, Austria.
Owlstone Medical is developing non-invasive breath tests that can be used in primary care settings to deter liver cirrhosis, as well as the earlier detection of liver disease NASH. The tests will be based on using both dietary limonene and a panel of oral EVOC probes including limonene.
Billy Boyle, co-founder and CEO at Owlstone Medical, said: “These results have further increased confidence that our liver disease tests have the potential to become powerful clinical tools in both primary and secondary care settings.
“With this stage of our development complete, we plan to evaluate the impact of additional EVOC probes on test performance when administered alongside limonene, in particular to confirm the ability to reliably detect earlier stages of liver disease.”
Owlstone has previously worked with the Cancer Research UK Cambridge Centre to run a clinical trial into its breath biopsy technology.