Validating the MicroKine Assay for Use in Identifying Personalized Precision Therapies for Pediatric Sepsis

Predxion Bio, Inc., South San Francisco MI

Investigators

Abstract

Project Summary/Abstract PreDxion Bio, LLC is a precision medicine diagnostic company developing an assay platform (the MicroKine? assay cartridge and reader) that measures serum proteins in less than 30 minutes from a single drop of blood. This fast, actionable information allows for the first time individualized precision medicine aimed at reducing pediatric morbidity and mortality in pediatric sepsis, the number one killer of children worldwide. The goal of this STTR is to move the current research grade MicroKine? platform to a validated, scalable, commercial grade alpha platform (Phase I), then to a fully automated beta platform (Phase II), while demonstrating the feasibility of using the platform in the clinical workflow. Using serum sample from pediatric patients with sepsis PreDxion will validate the MicroKine? platform demonstrating the feasibility of rapid risk stratification and identification of therapeutic targets by addressing the following aims: Specific Aim I) determine the feasibility of the alpha version of the MicroKine? assay to rapidly risk stratify pediatric patients with severe sepsis and Specific Aim II) demonstrate feasibility of rapidly determining the serum cytokines values in high-risk septic pediatric patients. Successful commercialization of the MicroKine? platform will provide the basis for expanding the current sepsis guidelines to individualized precision guidelines in high-risk individuals reducing the high rates of mortality in these individuals.