Celiac disease is a chronic gastrointestinal disorder most probably caused by an abnormal immune reaction to wheat gliadin and related gluten components from barley, rye and possibly oats.
The disease is characterized by flattening of the jejunal mucosa and intestinal lesions of variable severity in genetically predisposed individuals. Celiac disease does not fit the typical characteristics of an autoimmune disease; yet is associated with anti-tissue transglutaminase antibodies. Nevertheless, monitoring of gliadin antibodies is recommended in screening populations at risk for CD and other gluten-sensitive enteropathies.
Historically, serologic tests for gliadin antibodies generally lacked the accuracy required for proper diagnosis due to missing deamidated epitopes within the authentic gliadin fraction traditionally used in diagnostic test kits.
As a protein-focused biotech enterprise, DIARECT has successfully completed the recombinant protein approach by designing and producing a deamidated γ-gliadin isoform. By sequence design the epitopes correspond to the deamidated neo-epitopes, which in the natural antigen are formed by transglutaminase-mediated glutamine side chain deamidation.
Gliadin from DIARECT is produced in E. coli.