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Ventana Medical Systems, Inc. Receives First FDA 510(k) Clearance for H. pylori Antibody
Date:10/4/2011

TUCSON, Ariz., Oct. 4, 2011 /PRNewswire/ -- The VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (H. pylori) is the first H. pylori antibody to receive 510(k) clearance from the Food and Drug Administration (FDA). Developed by Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, the VENTANA H. pylori antibody, when used in immunohistochemical (IHC) staining, aids in the detection of Helicobacter pylori, a bacterium linked to chronic gastritis, ulcers and stomach cancer.

(Photo:  http://photos.prnewswire.com/prnh/20111004/LA79480)

"FDA clearance of the VENTANA H. pylori antibody proves that our product surpasses the industry standard," says Greg Yap, Ventana lifecycle leader for advanced staining assays. "By leveraging our expertise in industry-leading advanced staining assays and workflow solutions, we are delivering to pathologists another next-generation tool for treating potentially cancer-causing gastric infections.''  

The Centers for Disease Control and Prevention (CDC) estimates that approximately two-thirds of the world's population harbors the H. pylori bacterium, which damages the mucous coating that protects the stomach and duodenum. H. pylori causes peptic ulcers in nine out of 10 instances and studies have shown that those infected with H. pylori are nearly six times more likely to develop gastric cancer than those uninfected. In 1994, the International Agency for Research on Cancer (IARC) classified H. pylori as a carcinogen, or cancer-causing agent.

The VENTANA H. pylori antibody provides pathologists unprecedented views of the bacterium, allowing for a more accurate patient diagnosis. The high contrast staining of the organisms allows pathologists to view more bacteria than can be detected with special stains. With the H. pylori antibody, a
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SOURCE Ventana Medical Systems, Inc.
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