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

• Study published in Journal of Clinical and Translational Hepatology demonstrates alterations in breath VOCs can be used to differentially identify liver disease on breath
• Builds upon previous publication, identifying limonene as a breath biomarker to measure liver function and stage liver disease
• Supports Owlstone Medical’s development of breath-based diagnostic screening and staging tests for liver disease

Cambridge, UK, February 6 2023: 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-study[3] at Addenbrooke’s Hospital, Cambridge, UK, with Cancer Research UK for the CRUK Cambridge Centre Early Detection Program and International Alliance for Cancer Early Detection (CRUK grant refs: A25117 and RG97677), and the NIHR Cambridge Biomedical Research Centre (BRC-1215-20014), 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 results^[4], 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.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “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.”

Untargeted Liver Paper Video

1. https://www.xiahepublishing.com/2310-8819/JCTH-2022-00309; https://www.youtube.com/watch?v=BXXNHtDsdqc
2. https://www.cdc.gov/pcd/issues/2017/16_0287.htm
3. https://www.owlstonemedical.com/about/news/2019/jan/3/clinical-trial-launches-develop-breath-test-multip/
4. https://www.owlstonemedical.com/about/news/2020/sep/22/announcing-key-liver-study-results/

ENDS

Notes to Editors:
For more information please contact:
Sarah Jeffery, Zyme Communications
sarah.jeffery@zymecommunications.com
+44 (0) 7771-730919

Or

Frazer Hall, MEDiSTRAVA Consulting
Frazer.Hall@medistrava.com
+44 203 928 6900

What is Breath Biopsy^®?
Breath Biopsy represents an entirely new way to determine the chemical makeup of breath by measuring volatile organic compounds (VOCs), gaseous molecules that can be sampled quickly and non-invasively. VOCs originate from all parts of the body as the end product of metabolic processes, making Breath Biopsy applicable to a wide range of diseases including lung cancer, liver disease, and digestive disease. Breath also contains microscopic aerosol particles from the lungs and airways, which can contain a wide range of biomarkers including for infectious disease. The nature of Breath Biopsy therefore makes it perfectly suited to addressing two of the major challenges of healthcare today: early detection of disease and precision medicine.

About Owlstone Medical (www.owlstonemedical.com):
Owlstone Medical’s vision is to save 100,000 lives by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy^®, a unique platform capable of both biomarker discovery and use in routine clinical testing.

The platform includes ReCIVA^®, a proprietary sample collection device that can take stable breath samples anywhere, the world’s only commercial Breath Biopsy Laboratory located in Cambridge, U.K., and the Breath Biopsy VOC Atlas, the most extensive catalogue of identified volatile organic compounds (VOCs) commonly found on breath.  The Company’s technology is protected by over 120 granted and pending patents and has been used in more than 100 research papers.
Owlstone Medical’s Research Products and Services are being deployed at over 100 sites around the world with large pharmaceutical companies including AstraZeneca, Actelion (a J&J company), and GlaxoSmithKline, and leading academic institutions. Projects are supported by Breath Biopsy OMNI^®, the most advanced solution for reliable end-to-end global breath VOC analysis, which is helping researchers advance biomarker discovery and disease research and maximizing the chances of finding clinically relevant breath biomarkers.

The company has an active portfolio of Breath Biopsy tests in development for the early detection of lung cancer and liver disease, both areas of high unmet clinical need that represent multi-billion dollar market opportunities. In digestive health, clinical tests for Small Intestinal Bacterial Overgrowth and carbohydrate malabsorption are already on market, and breath testing is emerging as an effective way for patients to monitor and manage symptoms.