FDA Clears MBL Bullous Pemphigoid ELISA Test

Tuesday, September 23, 2008 General News
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WOBURN, Mass., Sept. 22 MBL International Corporation ofWoburn, Massachusetts is announcing that the United States Food and DrugAdministration, FDA, has cleared the BP180 and BP230 ELISA Kits for thedetection of Bullous Pemphigoid (BP), the new kits have been CE marked aswell. The new kits are seen as an advance in diagnosing Bullous Pemphigoid.

MBLI's Chief Executive Officer Dennis Walczewski, was pleased to offerthis new medical advance and was quoted as saying, "These new kits present asignificant advance in testing for this irritating skin malady and it is ourhope that improved testing can lead to better treatment."

Bullous Pemphigoid, which is an autoimmune blistering skin disease andcharacterized by mild to severe blisters covering the body, is diagnosed inapproximately 3,000 people each year in the United States. The BP180 andBP230 antibodies are characteristic of Bullous Pemphigoid and can be found inthe serum of affected patients.

The typical way to diagnose BP is using the immunofluorescence method (IF)to look at autoantibody patterns in patient tissue and a doctor's examination.MBL International is leading the way with these innovative ELISA kits, eachcontaining 48 wells coated with the recombinant BP180 and BP230 antigen.These kits are highly specific, sensitive and have a combined correlation ofgreater than 90% when compared to the IF method.

MBL International is a wholly-owned subsidiary of Medical and BiologicalLaboratories Co., Ltd, established over 35 years ago by 7 scientists as thefirst manufacturer of antibodies in Japan, and leading supplier of autoimmuneproducts. MBL International imports, manufactures, develops and sellsresearch reagents, kits and diagnostic products that target the autoimmunesystem. Recently, MBL International acquired Bion Enterprises, Ltd. which hasled to an increase in the company's array of diagnostic products that are usedto test for and diagnose severe skin diseases, viral infections and manyadditional autoimmune diseases.

SOURCE MBL International Corporation


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