Culture-Free Platform Rapidly Identifies Blood Stream Infections

Due to their immature immune systems, newborns are especially vulnerable to infections. It is estimated that 2.5 million neonates or infants in the first month of life die annually from sepsis, with the greatest impact in low- and middle-income countries. Since neonatal sepsis progresses quickly, it requires immediate treatment with intravenous fluids and antibiotics. The risk of death from neonatal sepsis increases by 7.6% for every hour that treatment is delayed. Now, a new diagnostic that combines molecular and microfluidic technologies is being developed to rapidly detect pathogens and drug resistance directly from blood in just a few hours.

Melio (Santa Clara, CA, USA) is creating a culture-free platform to identify bloodstream infections, including neonatal sepsis. By integrating advanced molecular and microfluidic technologies, Melio’s diagnostic aims to accurately detect and identify clinically significant pathogens and resistance markers directly from blood in under three hours, a significant improvement over the current standard of care, which requires culture and takes several days. If successful, the diagnostic's ability to test small blood volumes with high negative predictive value would address a critical gap in neonatal sepsis care. It would empower healthcare providers to make timely, targeted antimicrobial decisions—potentially saving lives, reducing unnecessary antibiotic use, and preventing adverse events or hospitalization during a crucial early stage of life. Melio has been awarded USD 3.5 million by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X, Boston, MA, USA) to develop and execute a technical feasibility plan for its culture-free platform.

“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.”

“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.”

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