bmd Obtains FDA Approval for Four new FIDIS™ Diagnostic Kits for Autoimmune Diseases
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bmd has received approval from the US Food and Drug Administration (FDA) for four of its Multiplex diagnostic kits for autoimmune diseases.
The kits in question are FIDIS Celiac IgG and FIDIS Celiac IgA, FIDIS Connective 10 and FIDIS Vasculitis. These kits cover a range of 17 different tests, unique tools that can identify a large number of autoimmune diseases in a very short time, thereby bringing significant benefits to both healthcare professionals and patients.
"The nigh-simultaneous approval of these four kits comes as bmd is building up its campaign to penetrate the North American market," said Dr. Patrick G Poty, CEO of bmd. "The FDA go-ahead strengthens bmd's leadership in very high throughput biological diagnostics in auto-immune diseases."
Used in conjunction with FIDIS, the multiplex based diagnostic system developed by bmd, these kits can quickly, accurately and clearly measure the profiles of several autoantibodies after just one hour of incubation.
FIDIS Celiac IgG and FIDIS Celiac IgA allow the simultaneous measurement of four autoantibodies (IgA anti-transglutaminase, IgA anti-gliadine, IgG anti-transglutaminase et IgG anti-gliadine), which are frequently associated with celiac disease. Patients with this disease, caused by a genetic abnormality, show intolerance for gluten. The highest incidence of celiac disease is among Caucasians and affects an increasing number of people (on average one in 133 in the US and one in 1,000 in Europe).
FIDIS Connective 10 identifies and measures in a single pass 10 autoantibodies linked to connective diseases. These are inflammatory diseases of the connective tissues, characterized by attacks on the joints or guts. These diseases include lupus erythematosus, CREST syndrome, scleroderma, polymyositis and Sjögren's syndrome.
FIDIS Vasculitis identifies the autoantibodies directed against proteins implicated in vasculitis, or inflammation of the lining of blood vessels (arteritis, phlebitis and lymphangitis).
