FDA approves H. pylori test for children

The U.S. Food and Drug Administration approved the first breath test to detect Helicobacter pylori bacterial infections in children ages 3-17, officials said. Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health, said the FDA first cleared the BreathTek UBT test for adults in 1996. The Centers for Disease Control and Prevention estimated approximately two-thirds of the world's population is infected with H. pylori, but many never have any symptoms. However, they have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected people, Gutierrez said. "Results from this test, when considered with a physician's assessment of the patient's history, other risk factors, and professional guidelines, can quickly indicate infection, which allows a physician to initiate appropriate health measures in a timely manner," Gutierrez said in a statement. The FDA based its approval of the BreathTek UBT test for children -- manufactured by Otsuka America Pharmaceutical of Rockville, Md. -- on a multi-center study of 176 patients, comparing its performance to a composite reference method and demonstrating 95.8 percent sensitivity and 99.2 percent specificity. An additional study, completed one to six months after therapy, supported use for post-treatment monitoring of patients.