Melio’s diagnostic integrates molecular and microfluidic technologies to rapidly detect pathogens and drug-resistance directly from blood within hours
(BOSTON: January 14, 2025) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award biotechnology company Melio US$3.5M to develop and execute a technical feasibility workplan for its culture-free platform designed to identify blood stream infections including neonatal sepsis.
Integrating cutting-edge molecular and microfluidic technologies, Melio’s diagnostic aims to enable accurate detection and identification of clinically relevant pathogens and actionable resistance markers, directly from blood within just 3 hours, whereas the current standard of care requires culture and takes multiple days. If successful, the diagnostic’s ability to test small blood volumes with high negative predictive value would fill a crucial gap in neonatal sepsis care by empowering healthcare providers to make early, targeted antimicrobial decisions—potentially saving lives, reducing unnecessary antibiotic exposure, and preventing adverse events or hospitalization at a critical early stage in life.
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. 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.
“Melio’s technology that utilizes direct from blood isolation using acoustic technology followed by melt curve identification, if successful, would represent a great stride made to detect neonatal sepsis, a syndrome that increases the likelihood of mortality the longer treatment is delayed,” said Erin Duffy, PhD, R&D Chief of CARB-X. “We look forward to working with Melio to understand their technology better and accelerate this diagnostic so that it may reach medical staff and patients more quickly.”
“Pathogen identification tests today compromise on either the sensitivity or breadth of pathogens detected. It takes a truly disruptive approach to break this tradeoff and deliver on the ‘holy grail’ for bloodstream infections,” said Mridu Sunha, PhD, Founder and CEO of Melio. “Melio has been working tirelessly to re-examine these technical challenges with out-of-the-box thinking, engineering innovative ways to interrogate and identify pathogens that deliver comprehensive testing for known pathogens while enabling detection of emerging or novel threats. We are excited to join the CARB-X ecosystem, which connects us with a network of clinical experts and policy leaders, fostering collaboration, shared learning, and significantly accelerating our path to commercialization.”
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 107 R&D projects in 13 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 UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Bill & Melinda 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
Melio Contact: Dr. Mridu Sinha, mridu@melio.tech
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 drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About Melio
Melio is committed to revolutionizing the healthcare industry by offering rapid infectious disease diagnostic solutions. By redefining standards of care, Melio aims to drive a shift toward precision healthcare, empowering clinicians to make informed, timely decisions for treatment for infections, reducing healthcare costs, and the overprescription of antibiotics. Melio’s first product focuses on providing a breakthrough in both speed and pathogen coverage for diagnosing bloodstream infections directly from a patient’s blood sample. Unlike the standard culture method, which serves as a bottleneck by taking days to deliver results, Melio’s technology offers an expedited alternative that could transform patient care.
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 is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency’s activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic and international partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR.
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