Prototype assay aims to examine microbial extracellular vesicles excreted in the urine for early detection of pneumonia caused by Pseudomonas aeruginosa
(BOSTON: February 11, 2025) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award biotechnology company Pearl Diagnostics US$1M to develop a low-cost, low turnaround time urine assay for the detection of pneumonia caused by Pseudomonas aeruginosa.
Pearl Diagnostics’ proprietary technology leverages their discovery that microbial extracellular vesicles (EVs) are released from organisms growing in the lungs and can be detected in the urine. This technology has already been successfully applied to detect lower respiratory infections caused by Aspergillus. The initial aim of the CARB-X-supported project is to evaluate the potential of Pearl Diagnostics’ technology for developing an assay to identify Pseudomonas aeruginosa infections.
Pneumonia, a lower-respiratory-tract infection (LRTI), is one of the leading causes of illness and death worldwide, particularly among vulnerable populations such as the elderly, young children, and those with compromised immune systems. Pneumonia is the leading infectious cause of death in children under five and in low-and-middle-income countries (LMICs), claiming the lives of over 700,000 children worldwide each year. In adults, LRTIs account for 2.5 million deaths annually, millions of hospitalizations, and significant healthcare costs.
Contributing to the rise of antibiotic resistance, broad-spectrum antibiotics are often prescribed to treat pneumonia without a clear diagnosis. The lack of rapid, accurate diagnostics exacerbates this issue, making it difficult to tailor treatments effectively and leading to overuse of antibiotics.
P. aeruginosa is a Gram-negative bacterium that predominantly affects immunocompromised individuals, frequently causing hospital-acquired and community-acquired infections. It is one of the six leading pathogens contributing to the burden of AMR and the top listed pathogens responsible for nosocomial infections. P. aeruginosa has developed significant resistance to antibiotics making infections increasingly difficult to eradicate.
“Pearl Diagnostics’ innovative prototype assay has the potential to offer a groundbreaking approach to early, accurate, and non-invasive diagnosis of lower-respiratory-tract infections,” said Erin Duffy, PhD, R&D Chief of CARB-X. “The ability to detect such infections through urine, especially for patients with compromised immune systems, could significantly shift the way we diagnose and manage these multidrug-resistant infections, enabling more targeted treatments and better patient outcomes.”
The rise of multidrug-resistant P. aeruginosa, which has been identified as a high priority pathogen by the WHO and an urgent threat by the CDC, has led to higher mortality rates, prolonged hospital stays, and increased healthcare costs. This trend underscores the urgent need for early detection. Early detection of P. aeruginosa has the potential to minimize the use of antibiotics and antifungals, decrease mortality rates, and shorten hospital stays associated with P. aeruginosa infections in healthcare settings worldwide.
“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 join the CARB-X portfolio in developing diagnostics that not only promise to save lives but also address the growing concern of antibiotic resistance. We’re excited about the potential impact our Pseudomonas aeruginosa test will have on patient outcomes and healthcare globally.”
In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibiotic development pipeline. More than 300 Expressions of Interest were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, prevention of invasive disease, diagnostics for neonatal sepsis, and proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Additional projects are under review, and new awards will be announced later this year. Register for the CARB-X newsletter to learn about upcoming funding calls that will be announced in 2025.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 112 R&D projects in 14 countries, and CARB-X product developers have made significant progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
Pearl Contact: info@pearldx.com
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target the most serious, resistant bacteria identified on global priority lists, syndromes with the greatest global morbidity and mortality, and performance characteristics necessary for patients. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About Pearl Diagnostics
Pearl Diagnostics Inc. (PearlDx) develops novel in-vitro diagnostic tests for non-invasive detection of life-threatening lung infections. The company’s Smart Antibody™ technology leverages our discovery that microbial extracellular vesicles (EVs) are released from organisms growing in the lungs. By responding to the urgent need for critical bacterial and fungal disease diagnostics highlighted by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), PearlDx is leading the way in medical innovation.
About BARDA and NIAID
The U.S. Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.4 billion in antimicrobial products since 2010. This investment has supported the development of over 160 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of four new antibiotics and FDA 510(k) clearance of eight diagnostics.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About the German Federal Ministry of Education and Research (BMBF)
Education and research are crucial foundations for our future. Thus, the promotion of education, science and research is a policy priority of the German Federal Government. The German Federal Ministry of Education and Research (BMBF) strengthens education at all stages of life and provides support for scientific research and innovation.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Public Health Agency of Canada
The Public Health Agency of Canada (PHAC), established in 2004, is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Its mission is to improve the health of all people and communities in Canada by addressing public health priorities through science, innovation, service delivery, and collaborative action. The Agency collaborates closely with all levels of government, non-government organizations, and international partners to build an effective public health system. PHAC has a strong history of addressing health threats, including collaboration on a One Health approach to antimicrobial resistance (AMR). As part of the recently launched Pan-Canadian Action Plan on AMR 2023-2027, PHAC is piloting an economic pull-incentive project to increase access to essential antimicrobial drugs not yet authorized in Canada to address priority unmet public health needs.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu