Image created by Dr. Michael J. Miller
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award AstraDx US$3M to demonstrate feasibility ahead of development for a robust, low-cost instrument to detect neonatal sepsis. AstraDx’s technology aims to perform pathogen detection, pathogen identification, and phenotypic antimicrobial susceptibility testing (AST) directly from whole blood and produce results within 4 hours.
Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections. AstraDx is using advanced digital imaging and signal processing to reduce the time to ID and AST results from days to just hours after a blood draw in an effort to ensure newborns receive the right antibiotics in time to save lives.
The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the greatest burden in low- and middle-income countries. Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics. The risk of death from neonatal sepsis increases 7.6% every hour a treatment is delayed.
“AstraDx’s innovative use of small sample volumes, advanced digital imaging and signal processing to detect pathogens and antimicrobial resistance within hours—rather than days—could represent a major leap forward in neonatal sepsis diagnostics,” said Erin Duffy, PhD, R&D Chief of CARB-X. “This solution could transform clinical decision-making, enabling timely, targeted treatment in critically vulnerable patients and helping combat antimicrobial resistance on a global scale.”
“We are incredibly honored to receive this recognition from CARB-X, which aligns fully with our mission of rapid AST and ID for all. This partnership is a proud moment for AstraDx, enabling us to get closer to our specific goal of saving newborns,” said Fran White, CEO of AstraDx. “Our system for diagnosing bloodstream infections for even the worst pathogens is designed to be easy to use and affordable for populations worldwide, including underserved populations. We are committed to meeting the challenge of emerging, highly antibiotic-resistant superbugs. Rapid ID and AST specifically for neonates, addresses the need for better life-saving treatment for this especially vulnerable population.“
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 111 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 already 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 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.