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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
