Owlstone Medical Attracts $2.3M Investment From Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation has made an equity investment of up to $2.3 million (circa £1.7 million) in Owlstone Medical for the development of a breath test for Pseudomonas aeruginosa (PA) detection in cystic fibrosis (CF) patients. 

The breath-based test would be suitable for both early detection of new PA infection and monitoring the chronic infection in CF patients, 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 CF patients’ lungs.

Initial work will focus on chronic PA to establish scientific proof-of-principle that VOCs on breath can identify this lung infection and be used as part of long-term infection monitoring. 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 CF care. 

CF is a progressive genetic disorder affecting more than 105,000 individuals worldwide.¹ 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 patients,² 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.

“Owlstone’s experience in the breath-based detection of infectious disease through projects with the U.S. Department of Defense,³ the Gates Foundation,⁴ 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,” Owlstone Medical Co-Founder/CEO Billy Boyle said. “Data from the study will also be entered into Owlstone’s Breath VOC Atlas,⁵ 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.”

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. PA is typically detected through sputum swab culture tests, however, many early cases are missed. 

Owlstone Medical’s vision is to save 100,000 lives by realizing the 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 the 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 more than 160 granted and pending patents and has been used in over 100 research papers.

Breath Biopsy represents a 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 body parts as the end product of metabolic processes, making Breath Biopsy applicable to numerous diseases including lung cancer, liver disease, and digestive disease. Breath Biopsy’s nature makes it perfectly suited to addressing two of the current major challenges of healthcare: early disease detection and precision medicine.

Owlstone Medical’s Research Products and Services are being deployed at over 100 sites worldwide 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 early lung cancer and liver disease detection, 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.

References
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/