Owlstone Medical Announces Investment of up to $2.3 Million USD from the Cystic Fibrosis Foundation to Develop a Breath Test for Pseudomonas aeruginosa Detection in Cystic Fibrosis Patients

Published on: 25 Mar 2025

  • Test to be developed for Pseudomonas aeruginosa detection in patients with cystic fibrosis suitable for both detection of new cases and monitoring of chronic infection
  • Support to demonstrate proof of principle in chronic infection to be provided to Owlstone in the form of an equity investment with potential for a follow-on study

 

Cambridge, UK, March 25, 2025: Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today announced that the Cystic Fibrosis Foundation has made an up to USD $2.3 million equity investment (circa £1.7 million) in Owlstone to develop a breath test for Pseudomonas aeruginosa (PA) detection in patients with cystic fibrosis (CF).

The goal of the investment is to develop a breath-based test suitable for both early detection of new PA infection and monitoring of chronic infection in patients with CF, with diagnostic accuracy at least comparable to sputum culture tests. Leveraging Owlstone’s expertise in volatile organic compound (VOC) analysis, the test will also be developed to distinguish PA from S. aureus and other common respiratory bacterial pathogens found in the lungs of people with CF.

Initial work will focus on chronic PA to establish scientific proof-of-principle that VOCs on breath can identify this lung infection and be utilized as part of long-term monitoring of infection. If successful, additional work can be organized to test the ability of this approach to detect new PA infections—an important event in the clinical care of people with CF.

CF is a progressive genetic disorder affecting over 105,000 individuals worldwide1. Characterized by excessive mucus production that traps pathogens in the lungs, CF causes severe lung infections and can lead to respiratory failure. PA, which affects an estimated 25% of CF patients2, represents a significant threat to people with CF. Once established in the lungs, PA is very difficult to eliminate, making early detection and aggressive treatment of infection critical.

PA is typically detected through sputum culture; however, this is difficult to perform in many children and is becoming increasingly challenging in adults with CF because of the beneficial effects of other therapies that reduce airway mucus and hence the ability to provide a suitable sputum sample.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Owlstone’s experience in the breath-based detection of infectious disease through projects with the U.S. Department of Defense3, the Gates Foundation4, and other partners, underpinned by our proprietary Breath Biopsy platform, places Owlstone in an excellent position to help improve outcomes for CF patients infected with Pseudomonas aeruginosa.” He added: “Data from the study will also be entered into Owlstone’s Breath VOC Atlas5, where it will continue to be used in clinical studies and analyses to support further biomarker and test development across a wide range of disease areas.”

  1. https://www.cff.org/intro-cf/about-cystic-fibrosis#:~:text=There%20are%20close%20to%2040%2C000,are%20many%20misconceptions%20about%20CF
  2. https://www.cff.org/managing-cf/pseudomonas#:~:text=Pseudomonas%20is%20a%20major%20cause,pools%2C%20hot%20tubs%20and%20sinks
  3. https://www.owlstonemedical.com/about/news/2023/mar/17/oml-wins-diu-contract/
  4. https://www.owlstonemedical.com/about/news/2024/apr/25/owlstonemedical-gatesfoundation/
  5. https://www.owlstonemedical.com/science-technology/breath-biopsy-voc-atlas/

ENDS

 

Notes to Editors:

CEO and Co-Founder, Owlstone Medical, Billy Boyle

Billy Boyle, co-founder and CEO at Owlstone Medical

 

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About Cystic Fibrosis and Pseudomonas aeruginosa

Cystic fibrosis (CF) is a progressive genetic disease that affects the lungs and other organs. Individuals with CF produce high levels of mucus that build up in the lungs, clogging the airways and trapping pathogens that can cause severe infection, potentially leading to respiratory failure. There are approximately 40,000 children and adults living with cystic fibrosis in the United States and an estimated 105,000 people have been diagnosed with CF across 94 countries.

Pseudomonas aeruginosa is a species of bacteria that are widely found thriving in humid environments. Normally harmless, the bacteria are opportunistic in individuals with compromised immune systems and infect an estimated 25% of patients with CF, often leading to pulmonary exacerbations. Once established in the airways, PA is very difficult to eliminate, making early detection and aggressive treatment of infection critical. PA is typically detected through sputum swab culture tests, however, many early cases are missed.

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® Breath Sampler, a proprietary sample collection device that can take stable breath samples anywhere, the world’s only commercial-scale 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 160 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), 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.

 

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. 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.