FDA clears Great Smokies' intestinal permeability test:
This article was originally published in Clinica
Executive Summary
Great Smokies Diagnostic Laboratory (GSDL) has received US FDA 510(k) clearance for its non-invasive test for measuring intestinal permeability, a measurement used to help diagnose gastrointestinal malabsorption syndromes, such as coeliac disease, Crohn's disease and irritable bowel syndrome. The intestinal permeability test kit is more sensitive than the existing d-xylose test, said the Asheville, North Carolina-based company, which also noted that it was the first commercial laboratory to offer intestinal permeability testing.