I-Corps: Translation Potential of Diagnostic Markers for Gastrointestinal Disease

This I-Corps project focuses on the development of a point-of-care diagnostic test for a common digestive system disease, irritable bowel syndrome (IBS). IBS symptoms include abdominal pain, bloating, constipation and diarrhea. IBS is associated with psychological disorders such as anxiety and stress and affects 25-45 million people in the U.S. and 10-15% people worldwide. IBS significantly affects the quality of life of patients, resulting in days off work or missed school, and costs healthcare systems more than $30 billion/year. Doctors cannot diagnose IBS based on symptoms alone, as people who do not have this disease may also show similar symptoms, such as diarrhea and constipation, due to other causes. Currently IBS is diagnosed by the process of elimination, where patients often go through several tests to rule out other issues, and even then, there is a chance of misdiagnosis. This project aims to address this issue by offering a point-of-care diagnostic test using patient biomarkers for early diagnosis of this disease. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. This solution is based on the development of a point-of-care diagnostic test that can be used by gastroenterologists and physicians in clinical settings to diagnose irritable bowel syndrome (IBS). This solution is based on the detection of specific metabolites that are present only in the human patient samples with IBS using a paper-based assay. The test works by using special proteins that recognize and bind to certain target molecules (metabolites) in a sample. When this binding happens, the target molecules push out indicator compounds that were originally attached to the proteins. This change creates a color signal, which reveals which metabolites are present and in what amount. The resulting indicators are chromatographically separated using a paper device, allowing the results to be seen and interpreted visually. The test is expected to lead to definitive and rapid diagnosis of IBS, allowing timely and targeted approaches to managing the disease and improving patient care and well-being. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.