CARB-X Funds $3.5M to Melio for Rapid Neonatal Sepsis Diagnostic

The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded a $3.5 million grant to Melio, a biotechnology company, to develop a rapid diagnostic tool to detect neonatal sepsis. This funding will help Melio advance its diagnostic platform, which integrates molecular and microfluidic technologies to identify bloodstream infections, including neonatal sepsis, directly from blood samples.¹

Melio’s diagnostic improves over traditional culture methods, which can take days to identify pathogens. By delivering results in three hours, the technology enables healthcare providers to identify the cause of infection and resistance markers, leading to faster and more targeted antimicrobial treatment. This speed is important in the fight against neonatal sepsis, which remains a leading cause of death in newborns, particularly in low—and middle-income countries.¹

Neonatal sepsis is a rapidly progressing infection, and delays in treatment increase the risk of death. According to recent studies, each hour of delayed treatment increases the risk of death by 7.6%. CARB-X’s support for Melio highlights the need for faster diagnostics in neonatal care. To understand the potential impact of this collaboration, Erin Duffy, chief of R&D at CARB-X, and Mridu Sinha, PhD, co-founder and CEO of Melio, to learn how this project could change the way neonatal sepsis is managed and treated.¹

In an email interview with Contagion, Duffy explained the value of rapid diagnostics in combating neonatal sepsis, “Traditional diagnostic methods, which rely on cultures, can take several days to identify pathogens, a delay that is especially dangerous in neonates, where rapid progression of infection can lead to severe outcomes. Melio’s technology, by contrast, aims to integrate cutting-edge molecular and microfluidic approaches to provide accurate pathogen identification and resistance markers directly from blood within just 3 hours.”

She continued, highlighting the key advantage of this approach, “This culture-free method offers a critical advantage by enabling healthcare providers to make early, targeted antimicrobial decisions, reducing unnecessary antibiotic use, and ultimately helping to combat the rise of resistant pathogens. This innovation not only has the potential to save lives but also supports responsible antibiotic stewardship by minimizing overuse, which is a key strategy in tackling antimicrobial resistance.”

Ensuring Global Accessibility

Duffy spoke about CARB-X’s commitment to making Melio’s technology accessible in regions with the highest neonatal sepsis mortality rates, “CARB-X is committed to ensuring that Melio’s diagnostic technology can be deployed effectively in regions with the highest neonatal sepsis mortality rates, including low—and middle-income countries. The benefit of entering the CARB-X portfolio is that Melio gains access to a network of subject matter experts who are deeply familiar with the challenges in neonatal care and the gaps in currently available diagnostic solutions," she said.

She added that these experts will play an essential role in the development of the product, “These experts will play a crucial role in advising Melio on how to develop a product that is not only scientifically advanced but also practical, affordable, and scalable for diverse healthcare settings. By leveraging the expertise within the CARB-X network, Melio is well positioned to create a product that addresses both the urgent clinical needs and the economic realities of regions with the highest burden of neonatal sepsis and antibiotic resistance.”

Duffy concluded, “This collaboration is key to developing a truly innovative tool that can save lives, reduce unnecessary antibiotic use, and make a significant impact on global health.”

Addressing Antimicrobial Resistance

Sinha explained how Melio’s technology tackles antimicrobial resistance, a growing concern in neonatal sepsis, “Antimicrobial resistance is a growing concern in neonates, especially for infection involving Escherichia coli, which is currently the most frequent bacteria found in neonatal sepsis. Additionally, it is now well established that infections caused by resistant pathogens are associated with higher mortality.”³

She detailed how Melio’s diagnostic can help address this challenge, “Melio's technology addresses this challenge by detecting key resistance markers, such as mecA associated with methicillin resistance in Staphylococcus species, vanA/B linked to resistance in Enterococcus species and under close surveillance in Staphylococcus aureus or CTX-M, responsible for extended-spectrum β-lactamase (ESBL) production in Enterobacteriaceae, which include E coli.”

“By identifying both pathogen species and key resistance markers, Melio empowers physicians to swiftly select the most effective antimicrobial treatment, improving outcomes—especially for vulnerable neonatal populations," Sinha said.

Impact of Speed on Neonatal Survival

Sinha further discussed how the speed of diagnosis can directly impact survival rates, emphasizing the critical need for timely intervention,“The current gold standard for diagnosing neonatal sepsis relies on blood cultures, which require 2 to 5 days for results, leading to broad-spectrum antibiotic empiric prescription. Melio’s goal is to change the status quo, providing highly accurate detection of pathogens in blood within just 3 hours.”

She explained how rapid diagnosis helps reduce unnecessary treatments, “If pathogens are present, it also identifies the species and key resistance markers, enabling faster, targeted treatment for improved outcomes, as it has been shown that delayed time to antibiotic administration was an independent risk factor for death.”⁴

Melio’s diagnostic technology also addresses another critical gap by ruling out infections, “Importantly, our technology has the capability to rule out the presence of pathogens in blood, addressing a critical unmet need in the management of neonates suspected of sepsis. Approximately 10% of the birthing population receives antibiotics at birth due to suspected sepsis, yet only 1 in 150 prescriptions is actually necessary.”⁵

Sinha explained that Melio’s approach could help reduce unnecessary antibiotic use, which in turn helps prevent both short-term and long-term adverse effects, “Our solution has the potential to significantly reduce antibiotic overuse and duration of exposure, minimize both short-term and long-term adverse events, and curb the emergence of drug resistance, while also decreasing unnecessary hospitalizations and mother-child separation. Melio has engaged extensively with clinicians and researchers to design a solution that aligns with their clinical workflows and addresses their most pressing challenges.”

The Role of Rapid Diagnostics in Improving Care

Experts in the field also underscore the importance of rapid diagnostics in neonatal care. Bill Benitz, Philip Sunshine, MD, professor of neonatology emeritus at Stanford University, explained the benefits of having timely diagnostic information, “Having rapidly available diagnostic information – the identity and antibiotic sensitivity of the circulating organism – allows the care providers to rapidly adjust the treatment regimen and target the second-line antibiotics, to optimally meet the baby’s needs, thus ensuring coverage of organisms that commonly exhibit resistance to standard first-line drugs. Besides, identification of a highly susceptible infecting organism allows reduction in antibiotic exposure.”

With CARB-X’s investment and support, Melio is positioned to make progress in addressing the challenges of neonatal sepsis. The diagnostic technology has the potential to improve early detection and enable more targeted antimicrobial therapy. This could improve patient outcomes and contribute to efforts to combat antimicrobial resistance, a growing global health threat.

References

1. CARB-X funds Melio to develop rapid diagnostic to detect neonatal sepsis. CARBX. January 14 ,2024. Accessed January 21, 2024. https://carb-x.org/carb-x-news/carb-x-funds-melio-to-develop-rapid-diagnostic-to-detect-neonatal-sepsis/

2. Stoll et al. Early-Onset Neonatal Sepsis 2015 to 2017, the Rise of Escherichia coli, and the Need for Novel Prevention Strategies, JAMA Pediatrics, 2020.

3. Global Antibiotic Research and Development Partnership (GARDP). (2022). https://gardp.org

4. Schmatz et al., Surviving Sepsis in a Referral Neonatal Intensive Care Unit: Association between Time to Antibiotic Administration and In-Hospital Outcomes, J Pediatr, 2020.

5. Schulman et al.Newborn Antibiotic Exposures and Association With Proven Bloodstream Infection, Pediatrics, 2019.