Owlstone Medical Presents Data Demonstrating Progress in Development of Breath Biopsy® Test for the Early Detection of Lung Cancer

Published on: 14 Jun 2023, under Cancer

  • Data presented at EACR 2023 Congress, Italy, 12-15 June
  • Findings presented from Phase 1 of the EVOLUTION study supports the application of D5-ethyl-β-glucuronide as a non-invasive EVOC® probe for early cancer detection
  • Additional promising EVOC probes for early lung cancer detection are in development


Cambridge, UK, June 14, 2023: Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today announced new data on the development of a screening test for the early detection of lung cancer. The results and research progress were presented in two posters at the EACR 2023 Congress, the annual meeting of the European Association for Cancer Research, held June 12-15 in Torino, Italy.

The poster ‘Proof-of-mechanism study for a diagnostic probe compound generating D5-ethanol as an on-breath reporter molecule for lung cancer – Evolution phase 1’ describes Owlstone’s efforts to establish D5-ethyl-β-glucuronide as a non-invasive EVOC® Probe for early cancer detection. Previous work, described in the poster, has demonstrated the ability to detect D5-ethanol cleaved from the probe through the action of extracellular β-glucuronidase in human cancer xenografted mice. Subsequently, Owlstone established the presence of extracellular β-glucuronidase in tissue samples from human lung cancers, including at stage 1, and the ability to reliably detect D5-ethanol in human breath samples through Breath Biopsy after administration of the EVOC probe.

In-human clinical trials are now underway with Phase 1a (safety assessment in healthy humans) and Phase 1b (dose optimization study in subjects with and without lung cancer) of the EVOLUTION study almost complete. Preliminary results presented show excellent safety and tolerability and demonstrate proof of mechanism through the successful measurement of D5-Ethanol levels in breath samples from lung cancer patients.

The poster ‘Using exogenous volatile organic compound (EVOC) probes to target tumour-associated aldo-keto reductase activity: a potential tool to detect lung cancer describes a complementary EVOC probe approach for the early detection of lung cancer based on aldo-keto reductase (AKR) activity, a metabolic process linked with the body’s reaction to the damaging effects of high levels of oxidative stress from cancer. This study, performed in vitro on human lung cancer cells, evaluated the expression of AKRs and demonstrated the ability to measure AKR-associated volatile reporters from cancer cells.


Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Through the studies presented, we are now confident we have the evidence we need to proceed to Phase 2 of the EVOLUTION study. This new multisite international trial will recruit up to 150 cases and 200 controls to optimize the test protocol and to establish test performance. We are also encouraged that a number of additional promising complementary EVOC probes are in our development pipeline, further enhancing our ability to address this high clinical need area.”

Lung cancer is one of the most common forms of cancer in the world with 2.21 million new cases in 2020 and is a leading cause of death (1.8 million globally in 20201), with 5-year survival at just 23.7% in the United States2. Early diagnosis can greatly improve the clinical outlook as patients diagnosed at an early stage have a 5-year survival rate of 56%, compared to just 5% for late stage3. While there are guidelines in place for the use of low dose computed tomography in the United States, uptake is less than 6%4 due to inconvenience, radiation dose, test performance, and in some cases cost. For this reason, there is an acute need for reliable and non-invasive screening solutions, and breath has emerged as a highly promising potential solution.

The posters presented can be viewed here:


  1. https://www.who.int/news-room/fact-sheets/detail/cancer 
  2. https://www.lung.org/research/state-of-lung-cancer/key-findings 
  3. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.html 
  4. https://www.lung.org/media/press-releases/state-of-lung-cancer-2022 


For more information please contact:

Dr Ben Rutter, Zyme Communications
+44 (0) 7920-770935


Frazer Hall, MEDiSTRAVA Consulting


+44 203 928 6900

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What is Breath Biopsy® (https://www.owlstonemedical.com/science-technology/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 (https://www.owlstonemedical.com/science-technology/evoc-probes/):

Exogenous VOC (EVOC) Probes are a reliable and highly sensitive alternative to the detection of endogenous biomarkers, as is standard in liquid biopsy, 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 (https://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 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.

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