Non-invasive biomarker specific for Crohn's disease diagnosis

Description:

Serum miRNA panel for non-invasive diagnosis and monitoring of Crohn’s disease

Market Need

Approximately 1.6 billion people in the US alone have inflammatory bowel disease, which includes Crohn’s disease. These chronic diseases, which have a significant impact on quality of life, can be treated but not cured. According to estimates based on insurance claims data, the direct annual cost of Crohn’s disease ranges from 8 -18 thousand dollars per patient, including the cost of lengthy diagnostic procedures for the disease. Because inflammation in Crohn’s can affect any part of the GI tract, it presents multi-symptomatically and many tests, including invasive endoscopy, biopsy, and radiological testing, are used to confirm diagnosis before treatment. Thus, there is a need for a non-invasive and more accurate means to diagnose Crohn’s disease.

Technology Overview

The Friedman lab has discovered that the expression of eleven specific miRNAs in a patient’s serum correlate specifically with Crohn’s disease. The miRNA panel was discovered in a cohort of Crohn’s patients when compared to control and the eleven specific miRNAs were confirmed using real-time RT-PCR. These eleven markers were then verified to be increased 2.7-8.7 fold in a second independent cohort of 46 patients of Crohn’s disease compared to healthy patients. To confirm that the miRNAs were specific to Crohn’s disease and not just intestinal inflammation, the same biomarkers were confirmed to be overexpressed in a third independent set of Crohn’s disease patients compared to celiac disease patients. Thus, this panel of serum miRNA biomarkers provides non-invasive confirmation of Crohn’s disease that would be useful for rapid diagnosis and monitoring of the disease.

Advantages

• Non-invasive biomarker present in urine

• Biomarker is specific to Crohn’s disease compared to general GI inflammation or celiac disease

• Amenable to point-of-care diagnostic

Application

• Diagnosis of Crohn’s Disease

• Monitoring treatment of Crohn’s Disease

Stage of Development: In vivo proof of concept

Case ID:

0463-10-Friedman

Web Published:

2/3/2017

Patent Information:

Title	Country	Serial No.	Patent No.	File Date	Issued Date
Compositions and Methods Useful for the Treatment and Diagnosis of Inflammatory Bowel Disease	Australia	2011312504		9/27/2011
Compositions and Methods Useful for the Treatment and Diagnosis of Inflammatory Bowel Disease	Canada	2,812,940		9/27/2011
Compositions and Methods Useful for the Treatment and Diagnosis of Inflammatory Bowel Disease	Europe	11831280.0		9/27/2011
Compositions and Methods Useful for the Treatment and Diagnosis of Inflammatory Bowel Disease	Israel	225519		9/27/2011
Compositions and Methods Useful for the Treatment and Diagnosis of Inflammatory Bowel Disease	Japan	2013-531711		3/27/2013
Compositions and Methods Useful for the Treatment and Diagnosis of Inflammatory Bowel Disease	United States	13/851,623	9,279,158	3/27/2013	3/8/2016