Monoclonal Antibody Approved for Stomach Bacterium

A monoclonal antibody that detects the bacterium Helicobacter pylori in gastric tissue biopsies is now officially available for pathologists.

The anti-H. pylori Rabbit Monoclonal Primary Antibody (SP48) is designed to qualitatively detect the presence of the bacteria in formalin-fixed, paraffin-embedded (FFPE) gastric biopsy tissue via light microscopy.

Immunohistochemical staining with this antibody product may aid in the diagnosis of H. pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic use.

The H. pylori antibody provides pathologists unprecedented views of the bacterium, allowing for a more accurate patient diagnosis. The high contrast staining of the organisms allows pathologists to view more bacteria than can be detected with special stains. A pathologist can clearly view the characteristic helical shape of the organism with the SP48 antibody. An infection can be detected and treated effectively even when very few organisms are present.

The antibody was developed by Ventana Medical Systems (Tucson, AZ, USA) and is fully integrated with the company’s BenchMark XT and BenchMark ULTRA slide staining instruments. The antibody has received 510(k) clearance from the US Food and Drug Administration (FDA, Silver Springs, MD, USA). Greg Yap, MBA, Ventana lifecycle leader for advanced staining assays, said, "FDA clearance of the VENTANA H. pylori antibody proves that our product surpasses the industry standard. By leveraging our expertise in industry-leading advanced staining assays and workflow solutions, we are delivering to pathologists another next-generation tool for treating potentially cancer-causing gastric infections.''

H. pylori infection is linked to chronic gastritis, ulcers, and stomach cancer. It is estimated that approximately two-thirds of the world's population harbors the H. pylori bacterium, which damages the mucous coating that protects the stomach and duodenum. This organism causes peptic ulcers in 9 out of 10 instances and studies have shown that those infected with it are nearly six times more likely to develop gastric cancer than those uninfected.

Related Links:
Ventana Medical Systems
US Food and Drug Administration