CARB-X Backs Neonatal Sepsis Diagnostic Platform By QuantaMatrix

Technology aims to deliver results within 6 hours from very small blood samples

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded QuantaMatrix Inc. US$2.85M to execute a workplan to develop its rapid diagnostic platform to detect sepsis, especially in vulnerable neonates. The test aims to deliver results within just 6 hours from very small blood samples of 1 to 2 milliliters.

If successful, the diagnostic could significantly improve patient outcomes as existing diagnostic methods can take several days. The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis. 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.

QuantaMatrix is applying its rapid blood culture technology directly from whole blood, with the addition of a brief enrichment step and its multi-marker QMAP “One-pot Assay” to address technological challenges that have limited innovation in this space. With minimal sample processing and a large commercial footprint, this program could make testing for neonatal sepsis more accessible, globally.

“Neonatal sepsis remains one of the most urgent diagnostic challenges due to the rapid disease progression, the time limitations of current culture-based methods, and the low sample volumes. QuantaMatrix’s platform has the potential to significantly improve early intervention and survival rates,” said Erin Duffy, PhD, R&D Chief of CARB-X. “CARB-X is proud to support the advancement of technologies that can bridge critical gaps in neonatal sepsis diagnostics and strengthen global efforts against antimicrobial resistance.”

“QuantaMatrix’s ambition extends beyond positioning ourselves at the forefront of rapid AST. Our vision is to become a global leader in Microbiology,” said Dr. SungHoon Kwon, President and CEO of QuantaMatrix.

In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibacterial development pipeline. More than 300 initial applications were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, novel approaches to the prevention of invasive disease caused by Staphylococcus aureus or Escherichia coli, diagnostics for neonatal sepsis, proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Ten awards were announced from the first cycle of the 2024 funding round. Additional projects from the second cycle will be announced this year. CARB-X will begin accepting applications for the second cycle of the 2025 funding round from December 1 to December 12. Register for the CARB-X newsletter to receive updates.

When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 117 R&D projects in 15 countries, and CARB-X product developers have made significant progress: 22 projects have advanced into or completed clinical trials; 14 remain active in clinical development, including late-stage clinical trials; and 3 products have reached the market. Additionally, more than 10 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), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Public Health Agency of Canada (PHAC), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), and Japan’s Ministry of Health. 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 publication is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.

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. For more information, visit https://carb-x.org/

About QuantaMatrix Inc.
QuantaMatrix Inc. is a leading in-vitro diagnostics company that develops rapid, innovative diagnostic solutions for critical needs in clinical microbiology and molecular biology. QuantaMatrix has already commercialized dRAST, their direct & Rapid Antimicrobial Susceptibility Test, which is a revolutionary step for sepsis management by enabling phenotypic antimicrobial susceptibility testing in 5-7 hours from positive blood culture. QuantaMatrix is now developing their next step in innovation, uRAST, an all-in-one solution capable of providing ultra-fast AST results direct-from-blood. Beyond sepsis, QuantaMatrix’s portfolio includes QMIA, a fully automated multiplex platform, featuring the QPLEX AlzPlus Assay for early Alzheimer’s disease prediction. For more information, visit www.quantamatrix.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 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 $2.4B 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.

As part of HHS, NIH is the primary U.S. federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.

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 Research, Technology, and Space and Research (BMFTR)
Research and technology are crucial foundations for our future. Thus, the promotion of science and research is a policy priority of the German Federal Government. The Federal Ministry of Research, Technology and Space (BMFTR) provides support for scientific re-search 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. For more information, visit www.novonordiskfonden.dk/en

Ministry of Economy and Finance of Italy
The Italian Ministry of Economy and Finance (MEF) performs the functions and tasks incumbent on the State in matters of economic and financial policy, budgeting, public investment planning and public debt management. The Ministry’s activities include coordinating and monitoring public spending and its trends, tax policies and the tax system and state assets. Moreover, the Ministry represents the Italian Government in the main European and international economic and financial fora, performs functions related to global governance and international financial cooperation, maintains relations with international economic, monetary, and financial institutions (such as the IMF, OECD, and Multilateral Development Banks), and negotiates and concludes international agreements and treaties with economic and financial content.

Japan’s Ministry of Health, Labour and Welfare (MHLW)
MHLW is a ministry of the Government of Japan whose missions are to improve and promote social welfare, social security, and public health in order to secure and improve the livelihoods of the people and contribute to economic development. Recognizing the urgent global public health threat posed by AMR, MHLW has been supporting various domestic and international efforts to advance research and development of antimicrobials. MHLW has committed to providing contributions to CARB-X from 2024 to 2026.

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 more information, visit www.bu.edu