Diagnostic Kit for Celiac Disease

A new diagnostic kit developed for celiac disease is called Fidis Celiac. The kit has been cleared by the U.S. Food and Drug Administration (FDA).

Fidis Celiac allows the simultaneous detection and semi-quantitation of three autoantibodies (IgA antitransglutaminase, IgA antigladin, IgG antigliadin) associated with celiac disease. Built on BMD's Fidis multiplex diagnostic system, Fidis Celiac is designed to determine the profile of these three autoantibodies rapidly and with extreme accuracy, and displays clear-cut results after one hour of incubation. The kit was developed by BioMedical Diagnostics (BMD, Marne-la-Vallee, France). BMD notes that it is the only company worldwide to offer a celiac disease diagnostic kit based on the Xmap platform of Lumenix (Austin, TX, USA).

Individuals with celiac disease, also known as gluten intolerance, have been shown to have a genetic predisposition for the disease, which is affecting an increasing number of patients around the world. It primarily affects one in 133 individuals in the United States and one in 1,000 in Europe. The disease affects people of Caucasian background but its incidence is increasing in other populations.

"BMD today has a clear lead in high-throughput biological diagnostics and we will leverage this to achieve our business objectives,” stated Patrick Poty, CEO of BMD. The company develops and markets advanced biologic diagnostic tools for the medical profession.




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