Inflammatory Bowel Disease - Non-Invasive Diagnosis

Nair, Padmanabhan

Abstract

Inflammatory Bowel Disease (IBD) remains an intractable chronic disease affecting nearly a quarter million individuals in the United States. A persistent inflammatory reaction is an integral component of this disease. Radiologic, endoscopic and pathologic examination of biopsy specimens are the current accepted approach for its diagnosis. While this is an essential set of procedures for confirming a diagnosis of IBD, it remains an invasive and extensive strategy for screening subjects and for frequent follow-up of established cases. Recent technological advances in the exfoliative biology of the colon have shown that colonic cells and inflammatory cells could be recovered in a viable state from stoop samples and examined for markers of colonic disease. It is now possible to apply this non-invasive approach to screen patients suspected of having IBD by demonstrating the presence of inflammatory cells in stools using two-color immunofluorescent flow cytometry of isolated cells. This new emerging science of COPROCYTOBIOLOGY, involving the isolation of cells from stool and screening, these cell populations for markers of colonic pathology (e.g. Malignancy, ID) is an exciting development. The objective of this SBIR, is to provide proof of concept demonstration for the reliable isolation of inflammatory cells from fecal isolates from stools of patients with IBD. The hypothesis is that inflammatory cells co- express CD-45 (the lymphoid lineage-specific, leucocyte common antigen) and COX-2 (prostaglandin endoperoxidase synthase). Enumeration of these cells by two-color immunofluorescent flow cytometry provides a means of developing an Index of Inflammatory Activity (IIA) which can be used for monitoring epithelial restitution of the colonic mucosa during periods of remission.

Proposed Commercial Applications

A standardized kit could be made available to clinicians for screening for IBD. The kit can be also used as an inexpensive way for monitoring patients with IBD for clinical response to therapy. Diagnostic laboratories, research centers, biology labs and oncology research centers will be potential users.