Patients who received blood and breath testing had lower observed rates of colonoscopy and upper endoscopy than those who received neither test.
A real-world study published in Frontiers in Gastroenterology indicates that the use of IBS-Smart and Trio-Smart testing in adults with suspected irritable bowel syndrome (IBS) is associated with lower healthcare resource utilization and reduced diagnostic costs.
The IBS-Smart test is a blood test that measures anti-CdtB and anti-vinculin antibodies associated with post-infectious IBS. The Trio-Smart test is a breath test that measures hydrogen, methane, and hydrogen sulfide to aid clinicians in evaluating small intestinal bacterial overgrowth, intestinal methanogen overgrowth, and intestinal sulfide overproduction.
Gemelli Biotech announced the findings of the study, which evaluated the diagnostic sequencing and economic impact of its noninvasive tests. Researchers reviewed the records of 219 adults treated at two US gastroenterology practices and found that tested cohorts had lower observed use of colonoscopy and upper endoscopy compared to patients who received neither test.
Impact on Diagnostic Procedures
According to the study, colonoscopy was performed in 60.7% of patients who received neither test. In comparison, the procedure was performed in 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 rates were 48.7% in the control group, compared to 31.3%, 41.9%, and 0.0% in the respective tested groups.
“What we saw is that selected use of noninvasive testing may help clinicians organize the diagnostic process more efficiently,” says Leonard Weinstock, MD, the study’s lead author and a gastroenterologist with Gastrointestinal Alliance, in a release. “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.”
Economic and Documentation Findings
The analysis found that captured diagnostic and gastroenterology office-visit costs averaged between $360 and $385 per patient per month in the tested groups, while costs for patients who received neither test averaged $960.39. In an exploratory model, IBS-Smart was associated with an estimated $526 in diagnostic cost savings per patient, while Trio-Smart was associated with $521 in savings.
The study also measured diagnostic persistence, which tracks whether a diagnosis recorded in a patient’s chart remains stable over time. Among untested patients, 25.6% had a stable charted diagnosis, whereas that figure ranged from 72.7% to 90.9% in the tested cohorts.
“IBS is a disorder of gut-brain interaction, and it demands clinical judgment,” says William B Salt II, MD, the study’s second author with IBS and Gut Microbiome Solutions, in a release. “A positive diagnostic strategy still means paying attention to alarm features and evaluating conditions that can present with an IBS-like phenotype.”
The study was funded by Gemelli Biotech, though the company was not involved in the study design, data collection, analysis, interpretation, or manuscript preparation.
“The economic signal is worth examining because it suggests that more structured diagnostic sequencing may reduce some downstream testing and office-visit costs,” says Raf Magar, study author with AHRM Inc, in a release. Magar notes that the findings are observational and that prospective studies are needed to determine if these associations translate into sustained savings.
