Owlstone Medical Publishes Data on the Use of Exhaled Volatile Organic Compounds as Biomarkers for Liver Disease Detection

Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy^® for applications in early disease detection and precision medicine, today announced the publication of a peer-reviewed study in the Journal of Clinical and Translational Hepatology, “Breath Biopsy to identify exhaled volatile organic compounds as biomarkers for liver cirrhosis detection”¹. The study identifies a set of volatile organic compounds (VOCs) that can identify patients with liver disease and separate them based on severity.

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are leading global causes of chronic liver disease. Fueled by increasing obesity and metabolic disease rates, approximately 66 million people have NAFLD in the United States alone, approximately 20% of whom will progress to NASH². Liver biopsy has long been the gold standard to stage liver disease, however it is costly, invasive, and can have serious complications, and so is unsuited for broad use in screening settings.

To address this need, Owlstone is developing a non-invasive, easy to use breath test that can be taken in primary care settings for the diagnosis of advanced NASH. The test, based on use of a panel of orally administered exogenous VOC (EVOC^®) probes, all of which are on the FDA’s Generally Recognized as Safe list, is intended to provide a way for clinicians to efficiently screen patients to identify those most likely to benefit from upcoming NASH therapeutics.

In the published study, performed as part of Owlstone’s Cancer Research UK funded PAN-study³ at Addenbrooke’s Hospital, Cambridge, UK, samples collected from 46 patients with advanced liver disease and 22 controls were investigated through Breath Biopsy OMNI^® global VOC analysis. This resulted in the identification of a number of VOCs that differed significantly between the groups, alteration of which appears to be driven primarily by impairment of liver function. One of the most significant was limonene, supporting previously published results⁴, with others with known links to liver health including 2-Pentanone and dimethyl selenide. On this basis a model with strong correlation to disease severity was generated (AUC of 0.95 ± 0.04 on cross-validated test sets), which as a panel holds great promise for liver disease detection and monitoring.

This study is an important component of the de-risking strategy for the development of Owlstone’s NASH test, which is currently in clinical trials. The company is in the process of identifying strategic partners to accelerate ongoing test development.

Previously we demonstrated the potential of limonene as a biomarker for liver disease severity, however liver disease is complex and comprehensive evaluation of liver function is not possible from a single biomarker. Now, following this additional excellent work by our internal team and external collaborators, we are pleased to be able to report this expanded set of VOCs, many of which are of exogenous origin and so may be suitable for development into EVOC probes.

Billy Boyle, co-founder and CEO at Owlstone Medical