A Possible Alternative to Endoscopy for Diagnosing, Monitoring IBD: Noninvasive Stool-based Technology

According to the Crohn’s and Colitis Foundation, inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn’s disease, affects around 1 in 100 people in the U.S.

Both conditions are costly to treat and even more so if they are not managed and monitored well. Patients with poorly managed IBD are more likely to make emergency room visits and experience hospitalizations.

Several years ago, a team of University of Pennsylvania and Precision Health Economics researchers estimated that the lifetime incremental cost for ulcerative colitis was $369,955 among patients who received their diagnosis as children and $132,396 for individuals 70 years or older, averaging $230,102 for a diagnosis at any age. For Crohn’s disease, their research showed that the lifetime incremental cost was $707,711 among patients who received their diagnosis as children, and $177,614 for patients 70 years or older, averaging $416,352 for a diagnosis at any age. On a population basis, those lifetime costs add up to $377 billion for people with ulcerative colitis and $498 billion for Crohn’s disease, according to this research.

Currently, IBD diagnosis and monitoring can be expensive, involving endoscopies and other methods. Noninvasive tests, such as those using blood- or stool-based biomarkers, have been recommended by the American Gastroenterological Association as a first-line tool for monitoring and managing ulcerative colitis.

Geneoscopy, a life sciences company based in St. Louis that focuses on devising gastrointestinal diagnostic tests, is developing a noninvasive stool RNA biomarker technology to predict therapeutic response and monitor disease activity in patients with IBD. The company will present data showing the platform’s potential diagnostic and disease monitoring capabilities at the Crohn’s & Colitis Foundation’s IBD Innovate 2024 Conference in Cambridge, Massachusetts, on April 9 and 10

Elizabeth M. Wurtzler, Ph.D.

The research, led by Elizabeth M. Wurtzler, Ph.D., director of research and development at Geneoscopy, analyzed stool-derived eukaryotic RNA (seRNA) biomarkers to predict treatment response and disease activity in patients with Crohn’s disease and ulcerative colitis. The test predicted patients with active disease and those in remission with 86% and 75% accuracy, respectively. For participants with active disease, the platform predicted those with mild and moderate disease with 86% and 95% accuracy, respectively.

Wurtzler and her colleagues conclude that noninvasive seRNA biomarkers can be used to predict treatment effectiveness and monitor mucosal healing in patients with IBD. Furthermore, the researchers indicate that these tools can be used by clinicians to diagnose and treat IBD more effectively.

Geneoscopy is collaborating with Adiso Therapeutics, based in Concord, Massachusetts, to develop its potential first-in-class oral, gut-restricted neutrophil modulator for the treatment of ulcerative colitis. The investigational drug called ADS051 is currently in a phase 2 study. Adiso is utilizing Geneoscopy’s seRNA biomarker technology to evaluate mucosal healing and predict patient response to investigational treatment in clinical trials.