Real-World IBS Study Links IBS-Smart® and Trio-Smart® Testing to Lower Use of Selected Diagnostic Procedures and Lower Captured Diagnostic Costs

ST. LOUIS & DUBLIN, Ohio & MESA, Ariz., August 18, 2026--Gemelli Biotech today announced the publication of a real-world study in Frontiers in Gastroenterology evaluating healthcare resource utilization following IBS-Smart® and Trio-Smart® testing in adults with suspected irritable bowel syndrome (IBS). Gemelli Biotech funded the study and manufactures both tests.

IBS is associated with substantial symptom burden and healthcare utilization. The published study suggests that selected use of IBS-Smart and Trio-Smart may influence diagnostic sequencing and reduce reliance on some downstream procedures.

Researchers reviewed the records of 219 adults with symptoms suggestive of IBS treated at two U.S. gastroenterology practices. Compared with patients who received neither test, the tested cohorts had lower captured diagnostic and office-visit costs, lower observed use of colonoscopy and upper endoscopy, and greater chart-level diagnostic persistence.

Colonoscopy was performed in 60.7% of patients who received neither test, compared with 50.0% of those who received IBS-Smart alone, 53.5% of those who received Trio-Smart alone, and 27.3% of patients who received both tests. Upper endoscopy was performed in 48.7% of controls, compared with 31.3%, 41.9%, and 0.0% in the respective tested groups.

Among patients first seen in 2018 or later, captured diagnostic and gastroenterology office-visit costs averaged approximately $360 to $385 per patient per month in the tested groups, compared with $960.39 among patients who received neither test.

"What we saw is that selected use of noninvasive testing may help clinicians organize the diagnostic process more efficiently," said Leonard Weinstock, MD, the study's lead author and a gastroenterologist with Gastrointestinal Alliance. "That does not mean these tests replace careful clinical evaluation, a Rome IV-based diagnosis, or appropriate rule-out testing. They are adjunctive tools—one part of a broader evidence-based approach."

One of the study's more notable findings involved diagnostic persistence—whether the diagnosis recorded in a patient's chart remained stable over time. Among untested patients, 25.6% had a stable charted diagnosis. In the tested cohorts, that figure ranged from 72.7% to 90.9%. The authors caution that chart-level stability reflects consistency of documentation and should not be interpreted as proof of diagnostic accuracy.

"IBS is a disorder of gut-brain interaction, and it demands clinical judgment," said William B. Salt II, MD, the study's second author with IBS and Gut Microbiome Solutions. "A positive diagnostic strategy still means paying attention to alarm features and evaluating conditions that can present with an IBS-like phenotype. These results support further study of where serologic and breath testing may fit within a stepwise, patient-centered pathway."