CHOSEN DIAGNOSTICS INC — Department of Health and Human Services STTR Phase I: NICHD

Description

The goal and significance of this project is to develop a clinically usable diagnostic test for gastrointestinal disease and to reduce healthcare costsNecrotizing enterocolitisNECis the most frequent and lethal gastrointestinal disease for preterm infantsIt affects newborns at a rate ofperUS births per year and has an average total in hospital treatment cost of $per patientAlthough first describedyears agoits cause is still unknownCurrent diagnosis relies on x ray imaging of free air in the intestinethis unfortunately detects onlyof the disease in its advanced stagesSince NEC is not diagnosed in a timely fashionthe intestine typically is destroyed by inflammation and requires surgical intervention to save the infantNearlyof infants who contract NEC dieSurvivors are faced with long term complicationssuch as shortened gutnutritional deficiency and neurodevelopmental delaysEven though this is an orphan diseaseNEC patients and survivors require $billion in medical careDevelopment of sensitive and specific diagnostic tools for NEC continues to be one of the most crucial areas of needWithout themNEC cannot be managed or treated appropriatelyApproached by neonatologists in the areathis collaboration directly sought a solution for this healthcare problemThe team has a prototype of a simple diagnostic test for NECNECDetectIts key advantage is its improved sensitivityFrom analysis ofpatient samplesNECDetect identified andgttrue positives and andgttrue negativesThe primary goal of this project is to conduct a larger scale study to test whether our biomarkers can not only identify individuals with diseasebut also be used as a prognostic test to predict the disease before its advancement to severe forms of NECAccuraterapidand inexpensive diagnostics can make personalized management of inflammatory bowel disease accessible for infantsBeyond its value of improving clinical management of patientseconomic benefit for hospitalshealthcare insurersand developing pharmaceutical markets is anticipated Necrotizing enterocolitisNECaffectspremature American infants each yearFor infants with NECmore than a third dieFollowing advanced stages of NECsurvivors end up with disabilities and a diminished quality of lifeA biomarker that improves diagnosis of the disease will lower mortality and life long health complicationsThe non invasive formats are necessary for fragile neonatescan be integrated in existing pathology lab workflowsreduce length of hospital stay and decrease healthcare costs!