Roche's Ventana unit has garnered 510(k) clearance for its anti-H. pylori rabbit monoclonal primary antibody. It is the first H. pylori antibody to receive FDA clearance, and, when used in immunohistochemical staining, helps detect the bacterium, according to the company.
The company's H. pylori antibody allows for a more accurate patient diagnosis, even when very few organisms are present. The high contrast staining of the organisms permits pathologists to view more bacteria than can be detected with special stains.
"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," explains 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."
H. pylori is linked to chronic gastritis, ulcers and stomach cancer. The CDC estimates roughly two-thirds of the world's population harbors the bacterium, which damages the mucous coating that protects the stomach and duodenum. The bacteria causes peptic ulcers in 9 out of 10 instances, and those infected with H. pylori are nearly 6 times more likely to develop gastric cancer than those who are uninfected.
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