A Medical Device Daily

Rules-Based Medicine (RBM; Austin, Texas) reported that the National Institutes of Health has awarded RBM a “Fast-Track” grant for the development of a diagnostic test for neonatal sepsis. The grant, entitled “Biomarker Profiles for Early Diagnosis of Sepsis in Neonates,” uses RBM’s HumanMAP^® platform to characterize and validate a pattern of biomarkers that can detect early signs of infection in newborns. This project will be performed in collaboration with the University of New Mexico (UNM; Albuquerque).

In a preliminary study, data indicated that a sensitive, specific diagnostic is possible where no predicate test exists today. The project, funded for $849,000, will examine samples provided by UNM from their Neonatal Intensive Care ward. RBM will administer the grant and perform all of the testing and statistical analysis.

“Infection is one of the biggest problems confronting newborns in intensive care,” said Michael Spain, MD, RBM’s chief medical officer. “Our collaboration with UNM has greatly facilitated the search for a solution to this problem.”

This project is being supported by Grant Number R44GM082038 from the National Institute of General Medical Sciences.

RBM is a multiplexed biomarker testing company that provides comprehensive protein biomarker products and services based on its Multi-Analyte Profiling (MAP) technology platform.