The goal and significance of this project is to develop a clinically-usable diagnostic test for gastrointestinal disease and to reduce healthcare costs. Necrotizing enterocolitis (NEC) is the most frequent and lethal gastrointestinal disease for preterm infants. It affects newborns at a rate of 1-3 per 1,000 US births per year and has an average total in-hospital treatment cost of $500,000 per patient. Although first described ~200 years ago, its cause is still unknown. Current diagnosis relies on x-ray imaging of free air in the intestine; this unfortunately detects only 44% of the disease in its advanced stages. Since NEC is not diagnosed in a timely fashion, the intestine typically is destroyed by inflammation and requires surgical intervention to save the infant. Nearly 30% of infants who contract NEC die. Survivors are faced with long-term complications, such as shortened gut, nutritional deficiency and neurodevelopmental delays. Even though this is an orphan disease, NEC patients and survivors require $5 billion in medical care. Development of sensitive and specific diagnostic tools for NEC continues to be one of the most crucial areas of need. Without them, NEC cannot be managed or treated appropriately. Approached by neonatologists in the area, this collaboration directly sought a solution for this healthcare problem. The team has a prototype of a simple diagnostic test for NEC, NECDetect. Its key advantage is its improved sensitivity. From analysis of 500+ patient samples, NECDetect identified >95% true positives and >95% true negatives. The primary goal of this project is to conduct a larger-scale study to test whether our biomarkers can not only identify individuals with disease, but also be used as a prognostic test to predict the disease before its advancement to severe forms of NEC. Accurate, rapid, and inexpensive diagnostics can make personalized management of inflammatory bowel disease accessible for infants. Beyond its value of improving clinical management of patients, economic benefit for hospitals, healthcare insurers, and developing pharmaceutical markets is anticipated.

Public Health Relevance

Necrotizing enterocolitis (NEC) affects 6,000 premature American infants each year. For infants with NEC, more than a third die. Following advanced stages of NEC, survivors end up with disabilities and a diminished quality of life. A biomarker that improves diagnosis of the disease will lower mortality and life-long health complications. The non-invasive formats are necessary for fragile neonates, can be integrated in existing pathology lab workflows, reduce length of hospital stay and decrease healthcare costs. !

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Small Business Technology Transfer (STTR) Grants - Phase I (R41)
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Special Emphasis Panel (ZRG1)
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Koso-Thomas, Marion
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Chosen Diagnostics, Inc.
New Orleans
United States
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