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

• 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, the global leader in Breath Biopsy^® for applications in early disease detection and precision medicine, announces 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/