Because of the devastating consequences of the failure to diagnose and treat a neonate with sepsis (an overwhelming and potentially fatal infection), as many as 600,000 neonates in the United States annually undergo an evaluation for sepsis during their birth hospitalization, although only 8,000 will later have been demonstrated to have culture-proven sepsis. Thus, 592,000 children annually undergo unnecessary, empiric antibiotic therapy with its attendant risks of potentially harmful side effects such as hearing loss, renal dysfunction, and others. Traditional tests for neonatal sepsis are insensitive, non-specific, or require 48-72 hours for completion. Therefore, there is an urgent need for rapid and reliable tests for the diagnosis of neonatal sepsis.

ProteoGenix, Inc. has been awarded its second NIH SBIR Phase I grant totaling $99,400 to discover and identify neonatal serum proteins that are differentially expressed as a result of sepsis that will serve as diagnostic markers. Our studies employ state-of-the-art proteomics approaches pioneered by ProteoGenix scientists to identify novel biomarkers of neonatal sepsis. The data obtained in this initial Phase I project will provide the foundation for the development of a sensitive, specific, and rapid point-of-service diagnostic test that will be commercialized and used to help save the lives of thousands of premature babies.