Drug news
FDA approves anti-Helicobacter pylori antibody
The FDA has given 510(K) approval to Ventana anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (H. pylori), from Ventana Medical Systems. This antibody is the first H. pylori antibody to receive such clearance and when used in immunohistochemical staining, aids in the detection of Helicobacter pylori, a bacterium linked to Chronic Gastritis, Ulcers and Stomach Cancer. The antibody provides pathologists unprecedented views of the bacterium, allowing for a more accurate patient diagnosis and is also fully integrated with the Ventana BenchMark XT and BenchMark Ultra slide staining instruments.
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