Marne-la-Vallée, France, November 2nd 2004 - BMD (BioMedical Diagnostics), one of Europe's top biology-led diagnostics companies, announces today that the US Food and Drug Administration (FDA) has granted their clearance for its celiac disease diagnostic kit, FIDIS [TM] Celiac, for sale in the USA. The system obtained European approval (CE marking) in April 2003 and is now compliant with American registration regulations.

FIDIS [TM] Celiac allows the simultaneous detection and semi-quantitation of three auto-antibodies (IgA anti-transglutaminase, IgA anti-gliadin, IgG anti-gliadin) associated with celiac disease. Built on BMD's FIDIS [TM] multiplex diagnostic system, FIDIS [TM] Celiac determinates a profile of these three auto-antibodies rapidly and with extreme accuracy, and displays clear-cut results after one hour of incubation. BMD is the only company worldwide to offer a celiac disease diagnostic kit based on the widely used and respected Luminex [R] platform. The Luminex platform is also used as the basis for BMD's other FIDIS offerings for autoimmune diseases, FIDIS [TM] Connective 10, FIDIS [TM] Thyro and FIDIS [TM] Rheuma.

Individuals with Celiac disease, which is also known as gluten intolerance, have been shown to have a genetic predisposition for the disease, which is affecting an increasing number of patients across the world. It primarily affects one in 133 individuals in the USA, and one in 1,000 in Europe. The most common symptoms are diarrhea, weight loss, malabsorption and general weakness. It affects people of Caucasian background but its incidence is increasing in other populations. FIDIS [TM] Celiac is therefore targeting an expanding market.

"The FDA's approval of FIDIS [TM] Celiac is really great news for BMD as it strengthens our position in the North American market where it is strategically important for us to increase our presence," said Patrick Poty, president and CEO of BMD. "BMD today has a clear lead in high throughput biological diagnostics and we will leverage this to achieve our business objectives."

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 during pregnancy, infectious mononucleosis, bacterial angina). BMD also offers immunochemical tests for diagnosing heart failure and other coronary problems.

FIDIS’ is BMD's flagship product: developed from Luminex’ Xmap technology, it enables high throughput diagnostics of autoimmune pathologies and represents a significant leap forward in technological advances 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 and North America.
http://www.bmd-net.com