PreDxion Bio, Inc. — Department of Health and Human Services STTR Phase I: NICHD

Description

Project Summary Abstract PreDxion BioLLC is a precision medicine diagnostic company developing an assay platformthe MicroKineassay cartridge and readerthat measures serum proteins in less thanminutes from a single drop of bloodThis fastactionable information allows for the first time individualized precision medicine aimed at reducing pediatric morbidity and mortality in pediatric sepsisthe number one killer of children worldwideThe goal of this STTR is to move the current research grade MicroKineplatform to a validatedscalablecommercial grade alpha platformPhase Ithen to a fully automated beta platformPhase IIwhile demonstrating the feasibility of using the platform in the clinical workflowUsing serum sample from pediatric patients with sepsis PreDxion will validate the MicroKineplatform demonstrating the feasibility of rapid risk stratification and identification of therapeutic targets by addressing the following aimsSpecific Aim Idetermine the feasibility of the alpha version of the MicroKineassay to rapidly risk stratify pediatric patients with severe sepsis and Specific Aim IIdemonstrate feasibility of rapidly determining the serum cytokines values in high risk septic pediatric patientsSuccessful commercialization of the MicroKineplatform 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 Project Narrative PreDxion Bio is developing a rapid serum protein assayMicroKinethat will provide clinicians information to guide precise individual therapies to children at highest risk from dying from sepsisthe number one killer of children worldwideThe assay would change the current way children with sepsis are treated by providing serum inflammatory protein levels in less thanminutes allowing clinicians to act quicklyThe MicroKineassay provides this information from a drop of blooda necessity when caring for children