The Cystic Fibrosis Foundation has committed up to US$2.3 million (about £1.7 million) in equity investment to Owlstone Medical for the development of a breath test to detect Pseudomonas aeruginosa (PA) infections in people with cystic fibrosis (CF). The Cambridge-based company announced the investment on March 25, 2025, marking a significant step forward in respiratory infection diagnostics for this patient population.

Addressing a critical clinical challenge

Pseudomonas aeruginosa represents a significant threat to CF patients, affecting approximately 25% of the population. Once established in the lungs, the pathogen is notoriously difficult to eradicate, making early detection and intervention critical to patient outcomes.

Current diagnostic approaches rely heavily on sputum culture, which presents substantial challenges. Many children struggle to produce adequate samples, and the effectiveness of modern CF therapies has ironically complicated diagnostics by reducing airway mucus production, making sample collection increasingly difficult even in adult patients.

The proposed breath test aims to achieve diagnostic accuracy at least comparable to sputum culture tests while offering a non-invasive alternative that could improve monitoring capabilities and early intervention.

Technical approach and development pathway

Owlstone’s breath test leverages the company’s expertise in volatile organic compound (VOC) analysis through their proprietary Breath Biopsy platform. The technology has been designed to detect specific VOC biomarkers on breath that can identify PA infection and distinguish it from other common respiratory pathogens in CF, including Staphylococcus aureus.

The development plan takes a phased approach, with initial work focusing on establishing proof-of-principle in patients with chronic PA infection. If successful, subsequent research will explore the test’s ability to detect new PA infections – a clinically significant event in CF management that often triggers aggressive antimicrobial intervention.

Billy Boyle, co-founder and CEO at Owlstone Medical, highlighted 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 implications for respiratory diagnostics

This investment represents a targeted response to the specific challenges of CF respiratory care, but carries potential implications for broader respiratory diagnostics. Cystic fibrosis affects over 105,000 individuals worldwide, with respiratory infections remaining a primary cause of morbidity and mortality.

Boyle noted that data collected from the study will contribute to Owlstone’s Breath VOC Atlas, supporting “further biomarker and test development across a wide range of disease areas.”