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Cystic Fibrosis Foundation Invests $2.3 Million in Owlstone Medical to Develop Breath-Based Pathogen Test

• Owlstone Medical has secured a $2.3 million equity investment from the Cystic Fibrosis Foundation to develop a breath test for detecting Pseudomonas aeruginosa infections in CF patients.

• The breath-based diagnostic aims to match or exceed the accuracy of traditional sputum culture tests while offering the ability to distinguish P. aeruginosa from other common respiratory pathogens like S. aureus.

• Initial research will focus on chronic P. aeruginosa infections to establish proof-of-principle, with potential expansion to early detection capabilities—critical for improving outcomes in CF patient care.

Cambridge-based Owlstone Medical has secured a significant financial boost for its innovative breath diagnostics platform, receiving up to $2.3 million (approximately £1.7 million) in equity investment from the Cystic Fibrosis Foundation. The funding will support the development of a breath test specifically designed to detect Pseudomonas aeruginosa (PA) infections in patients with cystic fibrosis.
The investment aims to create a non-invasive diagnostic tool that can both identify new PA infections early and monitor chronic infections, with accuracy at least comparable to current sputum culture tests. Leveraging Owlstone's expertise in volatile organic compound (VOC) analysis, the test will also be developed to differentiate PA from Staphylococcus aureus and other common respiratory bacterial pathogens that affect CF patients.

Critical Need in Cystic Fibrosis Care

Cystic fibrosis affects over 105,000 individuals worldwide and is characterized by excessive mucus production in the lungs that traps pathogens, leading to severe infections and potentially respiratory failure. Pseudomonas aeruginosa, which affects approximately 25% of CF patients, represents a particularly significant threat. Once established in the lungs, PA is extremely difficult to eliminate, making early detection and aggressive treatment critical for patient outcomes.
Currently, PA is typically detected through sputum culture analysis. However, this method presents challenges, especially for children and increasingly for adults with CF who benefit from therapies that reduce airway mucus—the very substance needed for an adequate sputum sample.

Development Approach and Timeline

The initial phase of development will focus on chronic PA infections to establish scientific proof-of-principle that VOCs in breath can reliably identify this lung infection and be utilized for long-term monitoring. If successful, the project will expand to test the approach's ability to detect new PA infections, which represents a crucial clinical event in CF care.
Billy Boyle, co-founder and CEO of Owlstone Medical, emphasized the company's relevant experience: "Owlstone's experience in the breath-based detection of infectious disease through projects with the U.S. Department of Defense, the Gates Foundation, 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."

Broader Impact on Breath Diagnostics

The data collected during this development will contribute to Owlstone's Breath VOC Atlas, enhancing the company's extensive catalogue of identified volatile organic compounds found in breath. This growing database supports ongoing clinical studies and analyses for biomarker and test development across multiple disease areas.
Owlstone Medical's technology is protected by over 160 granted and pending patents and has been referenced in more than 100 research papers. The company's Breath Biopsy platform includes the ReCIVA Breath Sampler, a proprietary collection device capable of taking stable breath samples anywhere, and the world's only commercial-scale Breath Biopsy Laboratory, located in Cambridge, UK.

Transformative Potential

This investment aligns with Owlstone Medical's vision to save 100,000 lives by realizing the promise of breath-based diagnostics. Breath Biopsy represents an entirely new approach to determining chemical makeup by measuring VOCs—gaseous molecules that can be sampled quickly and non-invasively. As these VOCs originate from all parts of the body as end products of metabolic processes, the technology has potential applications beyond respiratory conditions to include lung cancer, liver disease, and digestive disorders.
For CF patients specifically, a successful breath test for PA could significantly improve disease management by enabling earlier intervention and more effective monitoring of chronic infections, potentially reducing the burden of this challenging complication.
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