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www.fdanews.com/articles/70160-stratagene-announces-fda-clearance-of-ttg-autoimmune-test

Stratagene Announces FDA Clearance of tTG Autoimmune Test

March 22, 2005

Stratagene, a developer, manufacturer and marketer of specialized life science research and diagnostic products, announced that its wholly owned subsidiary, Hycor Biomedical, has received clearance from the FDA to market its Anti-Tissue Transglutaminase (tTG) IgG (Immunoglobulin G) autoimmune test in the U.S.

tTG is used in the diagnosis of celiac disease, which is a digestive disorder in which patients cannot tolerate a protein called gluten. When people with celiac disease eat foods containing gluten, their immune system responds by damaging the small intestine and interfering with the absorption of nutrients from food.

The new test complements the tTG IgA (Immunoglobulin A) test cleared by the FDA in 2004.