Blood test to distinguish inflammatory bowel disease from inflammatory bowel syndrome
Lead investigator: Thomas Stamato, PhD
Collaborators: Genisphere, LLC
Inflammatory bowel syndrome (IBS) is a common, mainly episodic condition that has been estimated to be responsible for one in six visits to a primary care provider. IBS symptoms are similar, however, to a rarer incidence of inflammatory bowel disease (IBD), a set of chronic autoimmune conditions requiring different management. At present, clinicians have no simple, non-invasive diagnostic test to distinguish IBS and IBD, which in the latter case, requires a definitive invasive procedure to diagnose (colonoscopy).
With no well-established standards to accurately diagnose IBD, there is a need for biomarkers that are cost-effective, rapid and provide insight into individual disease complexity and biology. In addressing the need for a non-invasive assessment of IBD in patients presenting with IBS, LIMR scientists have developed a blood test that may make this determination as an aid to improving personalized care.
LIMR’s technology is based on a blood-based biomarker signature defined by microRNA expression patterns in circulating blood exosomes. Specifically, the biomarker signature includes 31 platelet-derived miRNAs that correlate with distinct disease states. For distinguishing normal individuals from patients with clinically established ulcerative colitis, the most common form of IBD, the test results yielded a predictive score of 92.8 percent accuracy, 96.2 percent specificity and 89.5 percent sensitivity. The biomarker signature was validated at 88 percent accuracy through qPCR assays.
The incidence of IBD in developed countries has been skyrocketing, and the disorder is now becoming a global disease in newly industrialized countries as societies become more Westernized in diet and other factors. In the U.S., the CDC estimates that 1.3 percent of adults (about three million people) have been diagnosed with IBD. Foundations that support the annual World IBD Day (held in May) estimate 10 million affected individuals. In distinguishing IBD cases from the far larger number of individuals presenting with IBS, an accurate blood test would enable more rapid focus on the IBD affected population.
The global market for gastrointestinal disorder therapeutics and diagnostics is expected to grow from $51.8 billion in 2016 to $63.8 billion in 2021 at a compound annual growth rate of 4.3 percent from 2016–2021, according to the market information resource BCC Research.
Intellectual property position
Blood test to distinguish IBD vs IBS: Patent pending (co-invention with Genisphere, LLC)
Duttagupt R, DiRienzo S, Jiang R, Bowers J, Gollub J, Kao J, Kearney K, Rudolph D, Dawany NB, Showe MK, Stamato T, Getts RC and Jones KW. (2012). Genomewide maps of circulating miRNA biomarkers for ulcerative colitis. 2012. PLoS One 7: e31241.