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FDA NEWS RELEASE
For Immediate Release:
Feb. 24, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves First Helicobacter pylori Breath Test for Children

The first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2012.

The FDA first cleared the BreathTek UBT test for adults in 1996. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately two-thirds of the world’s population is infected with H. pylori. Most people with this infection never have any symptoms but have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected people.

“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,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health.

The FDA based its approval of the BreathTek UBT test for children 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 was done at 1 to 6 months after therapy to support use for post-treatment monitoring of patients. The sensitivity was 83.3 percent and the specificity was 100 percent.

BreathTek UBT is manufactured by Otsuka America Pharmaceutical based in Rockville, Md.

For more information:

FDA: Medical Devices
FDA: CDRH Office of In Vitro Diagnostic Device Evaluation and Safety

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