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Central Laboratories

Biomarkers for Celiac Disease Clinical Trials

  • October 2, 2017

Celiac disease (CD) is an autoimmune disorder which occurs in genetically predisposed individuals. Celiac disease is triggered by exposure to gluten containing products mainly wheat, rye and barley and causes damage to the small intestine, leading to villous atrophy. Currently, a strict gluten free diet is the only available treatment for the disease. Diagnosis and monitoring relies on serologic tests, genetic studies and histologic workup. The serology tests are recommended by American College of Gastroenterology as the first-line tests for screening individuals under risks and are also used to monitor the disease state.

Medpace offers four celiac disease marker testing that are primarily used in serologic screening and therapeutic monitoring in children and adults. Biomarkers include:

  • Tissue Transglutaminase Antibody, IgA (tTG IgA)
  • Tissue Transglutaminase Antibody, IgG (tTG IgG)
  • Deamidated Gliadin Peptide Antibody, IgA (DGP IgA)
  • Deamidated Gliadin Peptide Antibody, IgG (DGP IgG)

Testing is performed on the fully automated Phadia 250 system which uses fluoroenzymeimmunoassay technology. The assays are intended for semi-quantitative measurement of IgA/or IgG antibodies directed to tissue transglutaminase/or gliadin in human serum or plasma. The amount of antibodies detected in the sample is directly proportional to the fluorescent signal detected by the instrument. Interpretation of test results are provided as negative, equivocal and positive based on a single cut off.

As a full service, global CRO with an integrated central lab, Medpace has the scientific, operational and regulatory expertise to manage your celiac disease clinical trial. Contact Medpace