Owlstone Medical Publishes Exciting Liver Data on the use of an EVOC® Probe for the Early Detection of Cirrhosis

• Results show the potential of a Breath Biopsy^® test for the early detection of liver cirrhosis suitable for use in primary care settings

Cambridge, UK, November 9, 2023: Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy^® for applications in early disease detection and precision medicine, today announced the results of a peer-reviewed study in the journal Biomedicines – ‘Exogenous Volatile Organic Compound (EVOC^®) Breath Testing Maximizes Classification Performance for Subjects with Cirrhosis and Reveals Signs of Portal Hypertension¹. The results presented show the potential of Breath Biopsy for the early detection of liver cirrhosis in primary care

The study, in the Biomedicines Special Issue “New Challenges in the Study of Liver Diseases: From Molecular Pathogenesis to Therapeutic Approaches 2.0”, enrolled 29 ultrasound-confirmed cirrhosis cases and 29 healthy controls to assess the performance of Owlstone’s EVOC limonene breath test in cirrhosis detection.

Limonene is a safe chemical used in food manufacture and ingested mainly through the diet that accumulates in the liver, with a small fraction excreted in the breath following elevated exposure. In the study, all subjects showed a >100-fold limonene spike in breath after administration of the limonene EVOC probe, with significantly higher bioavailability seen in the cirrhosis group. Optimal test performance for the detection of cirrhosis was seen at 60 minutes post administration (83% sensitivity, 90% specificity, 89% PPV, 84% NPV, 0.91 AUC), a performance that suggests it has utility for screening.

Owlstone is developing non-invasive, easy to use, breath tests for liver disease, including for the early detection of cirrhosis. This test is planned to be used in primary care to screen individuals considered at high risk of having liver cirrhosis, with administration of the EVOC probe and collection of the sample to be performed in-clinic and the sample analyzed in a Breath Biopsy laboratory. Individuals with a positive test would then be expected to undergo further clinical diagnostic testing in line with the current clinical care pathway for formal diagnosis.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Compared to current approaches for cirrhosis detection available in primary care, Breath Biopsy offers several advantages. Breath collection is simple which enables it to be collected without the need for significant capital investment or specialist training. Further, the breath test in the study out-performs existing blood-based tests, and is non-invasive and cost-effective. Given the simplicity of Breath Biopsy, this published study demonstrates, for the first time, the potential of breath analysis as the basis of a non-invasive screening test that can be implemented in primary care to enable the early detection of cirrhosis with high sensitivity and specificity.”

References

1. https://www.mdpi.com/2227-9059/11/11/2957
2. https://www.owlstonemedical.com/about/news/2023/jun/22/owlstone-presents-liver-data/

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Liver disease accounts for two million deaths annually and is responsible for 4% of all deaths worldwide¹, largely attributable to complications of cirrhosis. It is estimated that more than 100 million people in the U.S. have some form of liver disease, however only 4.5 million have been diagnosed². Researchers estimate that 1 in 400 adults in the United States have cirrhosis³. Cirrhosis is also an expensive disease. In the US in 2016, liver-related healthcare costs were $32.5 billion, with two-thirds attributable to inpatient or emergency department care⁴.

Cirrhosis is an end-stage liver disease resulting from long-term exposure to chronic liver injuries, where scar tissue replaces healthy tissue, reducing liver function. Globally, the main causes of cirrhosis are hepatitis, alcohol-related liver disease, and metabolic dysfunction-associated steatohepatitis (MASH, formerly referred to as nonalcoholic steatohepatitis (NASH)). Deaths from liver cirrhosis continue to increase across the world, in part due to its late diagnosis, with up to 75%⁵ of cases diagnosed in secondary care with manifestation of decompensation when treatments are less effective at preserving liver function. Individuals with conditions such as type 2 diabetes, who are obese, or engage in heavy alcohol consumption are at a higher risk of having undiagnosed cirrhosis.

Detection of cirrhosis in primary care relies on biomarkers with relatively poor performance, while better-performing approaches such as transient elastography or imaging require substantial capital investment and specialist training and so are largely available only in secondary and tertiary care. The need for better and more accessible screening for cirrhosis is clear. Patients with a diagnosis of cirrhosis, before decompensation, can benefit from direct treatment of the underlying cause (e.g., viral suppression/eradication, alcohol abstinence, lifestyle improvements) and achieve a life expectancy similar to that of the general population⁶. Conversely, patients diagnosed with decompensation have a poor prognosis, with costly and invasive treatments such as liver transplant often the only option.

1. https://www.journal-of-hepatology.eu/article/S0168-8278(23)00194-0/fulltext
2. https://liverfoundation.org/about-your-liver/facts-about-liver-disease/how-many-people-have-liver-disease/
3. https://pubmed.ncbi.nlm.nih.gov/30949926/
4. https://www.sciencedirect.com/science/article/pii/S0168827823001940
5. https://pubmed.ncbi.nlm.nih.gov/24480518/; https://pubmed.ncbi.nlm.nih.gov/32020249/; https://pubmed.ncbi.nlm.nih.gov/35472313/
6. https://pubmed.ncbi.nlm.nih.gov/31981519/

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 EVOC^® Probes:

Exogenous VOC (EVOC) Probes are a reliable and highly sensitive alternative to the detection of endogenous biomarkers, which are often found at very low levels and so are difficult to detect in early disease. EVOC Probes instead are engineered to release a volatile reporter on breath after cleavage by a specific target pathway. This approach offers the advantage that compounds not normally found at significant levels in breath can be introduced into the body (individually or as a cocktail) to explore how they are absorbed, metabolized or excreted. Further, high levels can be administered, substantially improving signal-to-noise ratios compared to signals from endogenous sources and thus greatly improving reliability of detection.

About Owlstone Medical:

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 140 granted and pending patents and has been used in more 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), 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 a 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, under the OMED Health brand, clinical tests for Small Intestinal Bacterial Overgrowth and carbohydrate malabsorption are on market in the U.K., and a handheld device and app for longitudinal monitoring of digestive health is in development.