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

pathologist can clearly view the characteristic helical shape of the organism.  Even when very few organisms are present, an infection can be detected and treated effectively.

"As a pathologist with years of hospital experience, I believe our new H. pylori IHC test is an improvement to what is currently available for the diagnosis of H. pylori in tissue," says Dr. June Clements, Ventana staff pathologist. "The clean background and clear staining make identifying the organisms easier and faster. This, along with the specificity, provides the pathologist more confidence in the diagnosis."

For labs, the FDA clearance means less time spent validating the assay and more time running the tests, allowing for better lab workflow and quicker, more accurate patient diagnosis. The H. pylori antibody is also fully integrated with the VENTANA BenchMark XT and BenchMark ULTRA slide staining instruments.

"The key to our success in gaining FDA clearance was working with the FDA early in the process," says Sam Rua, director of regulatory affairs. "We met with the FDA, agreed to an approach for our 510(k) submission and adhered to that approach every step of the process. Because of that alignment, we were ultimately successful in gaining approval for the VENTANA H. pylori antibody."

About Ventana Medical Systems, Inc.

Ventana Medical Systems, Inc. ("VMSI") (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA solutions are used in clinical histology and drug development research laboratories worldwide. The company's "Smart Systems" – intuitive, integrated staining and workflow management platforms that optimize laboratory efficiencies to reduce errors – support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI
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SOURCE Ventana Medical Systems, Inc.
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