ibs-smart™ is a blood test that detects validated IBS biomarkers, anti-CdtB and anti-vinculin.
These markers are known to be elevated in a majority of patients with IBS-D or IBS-M and indicate the cause was gastroenteritis.
A 2,500+ patient study conducted at Cedars Sinai validated anti-CdtB and anti-vinculin as highly specific biomarkers for IBS.
An assessment of these biomarkers in IBS subtypes showed that they have broad applicability in diagnosing patients with IBS-D or IBS-M (IBS with a diarrheal component).
FOOD POISONING TO IBS
All common bacteria that cause food poisoning release Cytolethal Distending Toxin B (CdtB)
Anti-CdtB antibodies are generated to target the toxin. Because of molecular mimicry, anti-vinculin is produced
Anti-vinculin attacks an important protein in the gut, leading to nerve damage and dysmotility
IBS-D or IBS-M
The result is IBS with a diarrheal component. Symptoms include abdominal pain, bloating and diarrhea.
PATIENTS TO CONSIDER
Have IBS symptoms with a diarrheal component
Have no alarm symptoms (e.g., Blood in stool)
May not remember having had food poisoning
May have factors that increase risks associated with invasive procedures
ibs-smart™ has broad applicability to patients with diarrheal symptoms.
Up to 60% of patients with diarrheal IBS symptoms could be suffering from post-infectious IBS.
Pimentel M. et al. (2015) Development and Validation of a Biomarker for Diarrhea-Predominant Irritable Bowel Syndrome in Human Subjects. PLoS ONE 2015. PMID: 25970536
CLEAR LAB RESULTS
If either antibody is ‘Elevated,’ the test results can be considered positive and the patient can be confidently diagnosed with IBS-D or IBS-M.
If both antibodies are ‘Not Elevated,’ the test results can be considered non-indicative of post-infectious IBS. Further testing may be required in this case.
ibs-smartTM is a Lab Developed Test (LDT) conducted at a CLIA-certified (CAP accredited) Lab.
DOWNLOAD THE ibs-smart™ RESULTS INTERPRETATION GUIDE HERE.
With ibs-smart™, you can rule in IBS using a blood test and determine the original cause.
As a complement to your diagnostic protocol, ibs-smart™ can help you identify the most appropriate patients for invasive testing.
POST-TEST PROBABILITY OF IBS WITH POSITIVE RESULTS
Up to 98%
SPECIFICITY IN DISTINGUISHING BETWEEN IBS AND IBD
Up to 94%
ibs-smart™ IS PRICED FOR ACCESSIBILITY
UNCOVERED COST: $220
ibs-smart™ is covered at least in part by many common insurance plans.
The Patient Responsibility for Medicare and Medicaid patients is $0.
CPT Code: 83520
Billed once for each antibody
(Anti-CdtB and Anti-vinculin)
A published cost minimization model showed a test like ibs-smart™ could save a health system up to $800 per patient by preventing potentially unnecessary procedures.
THE SIMPLEST PATH