This document addresses the use of serological testing for biomarkers to aid in the screening, diagnosis and management of irritable bowel syndrome (IBS), including testing performed with IBSDetex^™ (Quest Diagnostics, Secaucus, New Jersey), ibs-smart^® (Gemelli Biotech, Los Angeles, CA) and IBSchek^® (Commonwealth Diagnostics International, Inc, Salem, MA). This document does not address any other type of testing for IBS including breath tests, fecal analysis, gene expression profiling or imaging.

Note: For additional information regarding related documents, please see:

• LAB.00016 Fecal Analysis in the Diagnosis of Intestinal Disorders
• LAB.00024 Immune Cell Function Assay

Position Statement

Investigational and Not Medically Necessary:

Serological testing for biomarkers of irritable bowel syndrome (for example, CdtB and anti-vinculin), using tests such as, IBSDetex, ibs-smart or IBSchek, is considered investigational and not medically necessary for screening, diagnosis or management of irritable bowel syndrome, and for all other indications.