Center for Technology Commercialization

Diagnostic and Prognostic for Crohn's Disease

(CHMC Ref. Id: 2006-0202)

Overview:

Standard therapies for IBD include steroids and immunomodulators which lead to a sustained remission in approximately 50% of patients. Currently, there are no reliable predictors of response, leading Dr. Denson and colleagues to prepare and stratify patient samples to directly address this deficiency. Obtaining colon biopsies from children with IBD at diagnosis, children with chronic IBD which has not responded to standard therapies, and normal controls, the analysis demonstrated a marked difference in the gene signatures for each sample set. More importantly, there exists a gene set that distinguishes between samples obtained at diagnosis from patients who ultimately responded to standard therapy versus those who were refractory to standard therapy over the first year following diagnosis. Some of these genes code for chemokines and matrix proteins which have been previously implicated in the pathogenesis of IBD; however, the majority of the genes in the signature have no known role in this pathology. Analysis of four responders and six refractory patients has shown that this assay will predict the refractory patients with 85% specificity and 100% sensitivity using the pattern of gene expression detected in one colon biopsy upon diagnosis. This assay would be ideal in the determination of therapy course upon IBD diagnosis.

Applications: