AstraDx’s technology to utilize advanced digital imaging and signal processing to provide results within hours versus days
(BOSTON: February 6, 2025) – 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.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
AstraDx Contact: media@astradx.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 AstraDx
AstraDx, Inc. is developing rapid pathogen identification (ID) and antimicrobial susceptibility testing (AST) for neonatal sepsis direct from a blood sample. Sepsis is the world’s leading cause of death and the most common and expensive U.S. hospital diagnosis. Survival depends on timely administration of the correct antibiotics, guided by laboratory diagnostics. Currently, ID and AST typically take days. Until results are available, doctors make their best guess on the correct antibiotic and hope the pathogen is susceptible. Newborns’ delicate physiologies and immature immune systems make them especially vulnerable to being on the wrong antibiotic, making rapid ID and AST for neonatal sepsis an urgent global priority. To address this challenge, 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, and to do so affordably. In this way, AstraDx is developing a global solution for improving patient treatment and management, to ensure newborns receive the right antibiotics in time to save lives. https://www.astradx.com
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