This story has been updated to include information on additional funding support for Visby Medical.
NEW YORK – CARB-X announced Tuesday that it will fund diagnostics firm Melio $3.5 million to develop a rapid assay for the detection of neonatal sepsis.
In a separate announcement on Wednesday, Visby Medical announced that it has received $3.9 million in additional funding from CARB-X to support its point-of-care gonorrhea assay using instrument-free PCR.
The Melio technology uses microfluidics, pathogen isolation with acoustic technology, molecular detection, and melt curve readouts paired with artificial intelligence-driven analytics, according to the firm's website.
The neonatal sepsis test will detect blood stream infection-causing pathogens and resistance markers from whole-blood samples with a three-hour turnaround time.
A University of California, San Diego spinout, Melio expects the test to impact early, targeted antimicrobial decisions for babies in neonatal intensive care units, reducing unnecessary antibiotic exposures.
"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," said Mridu Sunha, founder and CEO of Melio.
Approximately 2.5 million newborns die of sepsis each year before reaching the age of 1 month, according to a recent study, and the burden is greatest in low- and middle-income countries. Risk of death increases approximately 8 percent for each hour of delay in administering appropriate treatment.
The CARB-X funding to Melio was part of a solicitation issued in March 2024 which garnered 300 expressions of interest. CARB-X said that additional projects are currently under review and new awards will be announced later this year.
In August, CARB-X also provided $11.4 million in additional support to GenomeKey, a firm it initially funded in 2021 for rapid sepsis test development.
The new funding to Visby medical, meanwhile, builds on a $1.8 million CARB-X grant awarded in December 2023. It supports the development of an assay to detect Neisseria gonorrhoeae in urine samples from male patients and vaginal swabs and to distinguish strains susceptible to ciprofloxacin. In March 2023, Visby obtained 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for a second-generation point-of-care sexual health test to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women.
In a statement, Visby said the additional funding will integrate urine testing and ciprofloxacin susceptibility detection into its assay, called the Visby Medical Sexual Health Test. The company is also working on cost-cutting innovations and developing a companion app and AI tools for results interpretation.