Ventana Medical Systems, a member of the Roche Group, has secured 510(k) clearance from the Food and Drug Administration (FDA) for its Helicobacter pylori antibody.
H. pylori is a bacterium that causes chronic gastritis, ulcers and stomach cancer.
The antibody allows pathologists to accurately diagnose patients when used in immunohistochemical staining, as it enables them to view more bacteria than can be detected with special stains.
Ventana staff pathologist Dr June Clements said that the 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.
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