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bmd obtains FDA approval for four new FIDIS(TM) diagnostic kits for autoimmune diseases
Approval of FIDIS Connective
10, Vasculitis, Celiac IgC and Celiac IgA will boost bmd's penetration of the
North American market
Marne-la-Vallée, April 18 2006 - bmd (BioMedical Diagnostics SA), one of Europe's leading medical diagnostics companies, announces today that it has received approval from the US Food and Drug Administration (FDA) for four of its Multiplex diagnostic kits for autoimmune diseases. The FDA has responsibility for the surveillance of all biomedical products throughout the United States. 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. Today, bmd is the only company to
offer diagnostic tools for several autoimmune disease families (i.e. celiac,
blood vessel and systemic diseases), which are compatible with the modular
automated CARIS(TM)-FIDIS(TM) platform. bmd is planning to seek FDA
approval for three other kits, FIDIS DNA, FIDIS Thyro and FIDIS RF, aimed at
diagnosis or monitoring of other autoimmune diseases (Graves disease,
Hashimoto's disease and rheumatoid arthritis).
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). About bmd: bmd (BioMedical Diagnostics) develops and markets advanced biological diagnostic tools for the medical professions. The company boasts a unique combination of experience, knowledge and understanding of the biological diagnostics field. Founded in 1986, the company now holds a leading position in the diagnostics market, offering a wide range of solutions in the fields of autoimmune diseases (e.g. rheumatoid polyarthritis, lupus, thrombotic disease), allergies (food-related, respiratory, pediatric), and infectious diseases (viral pathologies, infectious mononucleosis, bacterial angina). bmd also offers immunochemical tests for diagnosing heart failure and other coronary problems.
FIDIS(TM) is bmd's flagship
product: developed from Luminex’ Xmap technology, in connection with CARIS(TM),
a front-end automation system, it enables high throughput diagnostics of
pathologies and represents a significant technological leap forward in
diagnostics.
Along with the development of its own products, bmd is involved in the manufacturing of products for other international distributors active across Europe, North Africa, Asia, Australia, Latin America and soon North America.
For more information please
contact:
Andrew Lloyd & Associates
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