The Cystic Fibrosis Foundation has agreed to invest up to $2.3 million in Owlstone Medical to develop a test that is designed to detect Pseudomonas infections from a person’s breath. In addition to detecting new infections, the test is intended to enable care teams to monitor chronic infections in people with cystic fibrosis.

A Pseudomonas infection is usually diagnosed by culturing a sputum sample — mucus or phlegm coughed up from the lungs. It is difficult to obtain these samples from children and becoming increasingly difficult to get them from people with CF who are taking modulator therapies that help clear mucus from the lungs. Sputum cultures also can miss early signs of infection.

“Developing high-performing diagnostic tests of lung infections that do not rely on sputum collection or invasive procedures is a high priority,” said David Nichols, MD, senior director of clinical research development at the CF Foundation. “Once Pseudomonas is established in the lungs, it is difficult to eliminate, so early detection and treatment is crucial in eradicating these infections.”

Owlstone will initially conduct a preclinical study on the feasibility of analyzing the breath to identify Pseudomonas lung infections and whether the technology can support longer term monitoring. The initial focus will be on chronic Pseudomonas, and, if successful, Owlstone says it plans to undertake additional research into the detection of new Pseudomonas infections to improve early diagnosis in people with CF.

Among those tested in the Foundation’s Patient Registry — excluding those who have had lung transplants — about 25% of people with CF were found to be positive for Pseudomonas in 2023, and nearly 13% of them had multi-drug-resistant strains of the bacteria. Accurate detection of which bacteria are present can reduce unnecessary antibiotic use that can lead to drug resistance. Likewise, earlier identification increases the ability to eliminate infections before they become persistent and more likely to develop antibiotic resistance.

In addition to a potential breath test, the Foundation is funding research into using blood and urine samples from people with CF to determine when infections are present in the lungs.