BALTIMORE – June 17, 2025 – Pearl Diagnostics, a Johns Hopkins University spin-off specializing in non-invasive diagnostics for lung infections, announced today it has received a strategic investment from the Cystic Fibrosis Foundation to support the development of a urine-based assay for detecting Pseudomonas aeruginosa in people with cystic fibrosis.
Addressing a Critical Challenge in Cystic Fibrosis
Cystic fibrosis is a genetic disorder characterized by persistent lung infections and progressive respiratory decline. Over time, people living with CF often develop infections from pathogens such as Staphylococcus aureus, Haemophilus influenzae, and, most notably, Pseudomonas aeruginosa and Aspergillus species. Chronic infection with Pseudomonas aeruginosa is a leading cause of morbidity and mortality in cystic fibrosis, while Aspergillus-associated diseases are increasingly recognized as complicating factors, especially in lung transplant recipients.
Pseudomonas aeruginosa is the dominant pathogen in the CF lung, and once established, chronic infection is almost inevitable, driving progressive lung damage and frequent exacerbations. In recent years, the importance of Aspergillus-associated diseases in CF and lung transplant recipients has also become increasingly recognized, further complicating clinical management.
Current gold-standard methods for detecting Pseudomonas aeruginosa rely on culturing sputum, but sputum is increasingly difficult to obtain in people with cystic fibrosis due to improved lung function from modulator therapies. For patients who cannot spontaneously expectorate, induction may be necessary, or even a bronchoalveolar lavage, but this is invasive, may miss early or low-level infections, and is not practical for routine monitoring. This creates a significant clinical gap given how aggressive and damaging P. aeruginosacan be in the CF lung. There is a growing need for non-invasive, more accessible approaches, such as using urine or blood samples, for detecting infection earlier, more reliably, and without the need for sputum.
Pearl Diagnostics’ Innovative Approach
Pearl Diagnostics has pioneered urine-based diagnostics for lung infections, leveraging the discovery that microorganisms growing in the lungs secrete extracellular vesicles (EVs) that are excreted in urine. This technology is already being applied to detect Aspergillus infections, with Pearl’s MycoMEIA–Aspergillus assay, CE marked in Europe and submitted to the FDA for clearance, expected in August 2025. Pearl’s MycoMEIA–Aspergillus assay also addresses the challenge of detecting Aspergillus colonization and disease in CF and lung transplant recipients. Assisted in part by the CF Foundation, Pearl has generated data suggesting that its MycoMEIA technology can help diagnose pulmonary aspergillosis and airway fungal colonization in these populations.
Now, with support from the Foundation, Pearl is advancing the development of a prototype urine assay for Pseudomonas aeruginosa in people with CF. Pearl’s approach utilizes antibodies targeting highly abundant proteins in and on Pseudomonas Extracellular Vesicles, to enable sensitive, non-invasive detection. Proof-of-concept studies have shown robust signals in people with Pseudomonas pneumonia, with ongoing work to optimize the assay for CF-specific infections. “Pearl Diagnostics’ Smart Antibody™ technology represents a paradigm shift in diagnosing lung infections. By harnessing the power of microbial EVs, we’re opening new doors for rapid, non-invasive diagnostics,” said DeWayne Davenport, CEO of Pearl Diagnostics. “We are honored to be a part of the Foundation portfolio, developing diagnostics that not only promise to save lives but also address the growing concern of Pseudomonas in CF. We’re excited about the potential impact our Pseudomonas aeruginosa test will have on patient outcomes and healthcare globally.”
Potential Impact
Early, non-invasive detection of Pseudomonas and Aspergillus infections could revolutionize CF care by enabling timely, targeted antimicrobial therapy, reducing unnecessary antibiotic use, minimizing hospitalizations, and improving patient outcomes. Pearl’s urine-based assays offer the promise of rapid, accessible diagnostics for both bacterial and fungal lung infections, addressing a significant gap in current clinical practice.
About Pearl Diagnostics
Pearl Diagnostics Inc. (PearlDx) is a Johns Hopkins spin-off company that develops novel in-vitro diagnostic tests for non-invasive detection of life-threatening lung infections. Its proprietary Smart Antibody™ technology detects microbial extracellular vesicles in urine, enabling early diagnosis of bacterial and fungal infections. PearlDx’s MycoMEIA–Aspergillus assay is CE marked in Europe and under FDA review, with clearance expected in August 2025.
Media Contacts:
Pearl Diagnostics: info@pearldx.com
