FDA Clears MBL Bullous Pemphigoid ELISA Test

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Sep 2008 - 1:00 PDT

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MBL International Corporation of Woburn, Massachusetts is announcing that the United States Food and Drug Administration, FDA, has cleared the BP180 and BP230 ELISA Kits for the detection of Bullous Pemphigoid (BP), the new kits have been CE marked as well. The new kits are seen as an advance in diagnosing Bullous Pemphigoid.

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

Bullous Pemphigoid, which is an autoimmune blistering skin disease and characterized by mild to severe blisters covering the body, is diagnosed in approximately 3,000 people each year in the United States. The BP180 and BP230 antibodies are characteristic of Bullous Pemphigoid and can be found in the 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, each containing 48 wells coated with the recombinant BP180 and BP230 antigen. These kits are highly specific, sensitive and have a combined correlation of greater than 90% when compared to the IF method.

MBL International is a wholly-owned subsidiary of Medical and Biological Laboratories Co., Ltd, established over 35 years ago by 7 scientists as the first manufacturer of antibodies in Japan, and leading supplier of autoimmune products. MBL International imports, manufactures, develops and sells research reagents, kits and diagnostic products that target the autoimmune system. Recently, MBL International acquired Bion Enterprises, Ltd. which has led to an increase in the company's array of diagnostic products that are used to test for and diagnose severe skin diseases, viral infections and many additional autoimmune diseases.

MBL International Corporation
http://www.mblintl.com

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