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news.Ventana Medical Systems has secured 510(k) clearance from the Food and Drug Administration (FDA) for its H. pylori antibody.
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The Ventana H. pylori antibody is used in the detection of Helicobacter pylori, a bacterium which causes chronic gastritis, ulcers and stomach cancer.
The antibody helps in accurate patient diagnosis as the high contrast staining of the organisms, using immunohistochemical (IHC) staining allows pathologists to view more bacteria than can be detected with special stains.
Ventana staff pathologist Dr. June Clements said the H. pylori IHC test is an improvement to what is currently available for the diagnosis of H. pylori in tissue.
"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," Clements added.