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.”
The economic analysis used a payer-proxy perspective in 2022 U.S. dollars and included captured diagnostic tests and gastroenterology office visits. In an exploratory propensity-matched model, IBS-Smart was associated with an estimated $526 in diagnostic cost savings per patient. A separate model for Trio-Smart estimated diagnostic-test cost savings of $521.
“The economic signal is worth examining because it suggests that more structured diagnostic sequencing may reduce some downstream testing and office-visit costs,” said Raf Magar, study author with AHRM Inc. “However, these findings are observational and hypothesis-generating. The analysis did not capture the full economic burden of IBS, including emergency care, primary care, lost productivity, dietary costs, or all downstream treatment. Prospective studies are needed to determine whether these associations translate into sustained savings for patients, providers, and health plans.”
The authors note several limitations, including the retrospective design, clinician-selected testing, potential coding and selection bias, incomplete standardization of rule-out testing, and the small number of patients who received both tests. The study did not include patient-reported outcomes such as symptom improvement or quality of life.
The study was funded by Gemelli Biotech, the manufacturer of IBS-Smart and Trio-Smart. According to the published article, the funder was not involved in the study design, data collection, analysis, interpretation of data, manuscript preparation, or the decision to submit the article for publication.
About the study
“A real-world assessment of healthcare resource utilization following IBS-Smart® and Trio-Smart® testing in patients with suspected irritable bowel syndrome,” by Leonard Weinstock, William B. Salt II, Lynn Cherry, Christopher Tyson, and Raf Magar, was published in Frontiers in Gastroenterology on July 23, 2026. DOI: https://doi.org/10.3389/fgstr.2026.1681818.
About IBS-Smart® and Trio-Smart®
The following product information is provided by Gemelli Biotech and was not evaluated as a product-validation endpoint in the published study. IBS-Smart is an at-home sample-collection, mail-in blood test that measures anti-CdtB and anti-vinculin antibodies associated with post-infectious IBS. Trio-Smart is an at-home, mail-in breath test that measures hydrogen, methane, and hydrogen sulfide. Its results may aid clinicians evaluating patients for small intestinal bacterial overgrowth (SIBO), intestinal methanogen overgrowth (IMO), and intestinal sulfide overproduction (ISO). Test results should be interpreted by a qualified healthcare professional in the context of the patient’s clinical history and other appropriate evaluation.
Learn more about Trio-Smart at triosmartbreath.com and IBS-Smart at ibssmart.com.
About Gemelli Biotech
Gemelli Biotech develops and distributes noninvasive, at-home sample-collection and mail-in diagnostic tests for gastrointestinal conditions. The company seeks to translate advances in gastrointestinal and microbiome science into practical tests that provide clinicians and patients with clinically relevant biomarker and breath-gas information.
Gemelli’s products include Trio-Smart®, a three-gas breath test that measures hydrogen, methane, and hydrogen sulfide and may aid in the evaluation of SIBO, IMO, and ISO; IBS-Smart®, a blood test that measures anti-CdtB and anti-vinculin antibodies associated with post-infectious IBS; and Trio-Smart Malabsorption, a breath test used to evaluate carbohydrate malabsorption following lactose, fructose, or sucrose consumption.
Gemelli tests may be ordered through a healthcare provider or, where available, through Gemelli’s online patient platform. Laboratory and regulatory information should be confirmed directly with Gemelli Biotech. Visit gemellibiotech.com to learn more.
Study context and limitations
The study was retrospective and observational. Associations reported in the study do not establish causality. The published article states that IBS-Smart and Trio-Smart do not replace Rome IV-based clinical evaluation, assessment of alarm features, or guideline-recommended rule-out testing.
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