Celiac disease (CD) is an inflammatory condition caused by exposure to dietary gluten proteins in genetically predisposed individuals. Despite improvements in recent years, the diagnosis rate for CD remains low, due a combination of various factors, including alternative diagnoses (often irritable bowel syndrome), asymptomatic and latent disease, and misconceptions about the rarity of the disease. There is an unmet need for serological tests with better diagnostic accuracy.
A panel of recombinant human monoclonal antibodies (hmAbs) have been generated by expression cloning of immunoglobulin genes from single plasma cells isolated from intestinal lesion of patients with celiac disease, with reactivity to either of the two most disease-relevant antigens (TG2, gliadin). Prototype serological tests have been developed based on the abovementioned disease-specific monoclonal antibodies, and evaluated on untreated CD patients and control subjects. Preliminary data for the prototype tests indicate superiority to currently leading marketed tests (91-94% sensitivity at 98% specificity).
The novel serological tests will address the need for improved non-invasive testing for coeliac disease, increasing diagnosis rate and reducing the need for endoscopies.
An international patent application protecting the invention has been filed.