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Clinical validation of iVYLISA assays:

Manuscript published in Gut 2015: “Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing”. Moreno ML, Cebolla Á, Muñoz-Suano A, Carrillo-Carrion.

Manuscript published in American Journal of Gastroenterology 2016: “Detection of gluten peptides in stools reveals limitations in the use of serological tests and dietary questionnaires for monitoring adherence to the gluten-free diet in coeliac disease patients”. Comino I, Fernández-Bañares F, Esteve M, Ortigosa L, Castillejo G, León F, Marinich J, Muñoz-Suano A, Cebolla A, Sousa C.

Manuscript published in American Journal of Clinical Nutrition 2012: “Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces”. Comino I, Real A, Vivas S, Síglez MA, Caminero A, Nistal E, Casqueiro J, Rodríguez-Herrera A, Cebolla A, Sousa C.

What is the potential market in the US?

  • 3.2M people in USA estimated to have Celiac Disease (2).
  • 60% adhering to Gluten Free Diet worry about accidental ingestion ( 3).
  • 92% of Celiac Disease interested in at-home testing.
  • 6x per year = average at-home stool test frequency desired.
  • 19x per year = average at-home urine test frequency desired.