Children Now Eligible for Screening Test for Bacterium
FRIDAY, Feb. 24 -- The U.S. Food and Drug Administration has expanded approval for a breath test that screens for a common ulcer-causing germ, to include children aged 3 years to 17.
The Helicobacter pylori bacterium causes stomach inflammation (gastritis) and ulcers, and increases an infected person's risk of gastric cancer and a certain form of lymphoma. In a news release, the FDA said the BreathTak UBT test, approved for adults in 1996, is now sanctioned for children.
The U.S. Centers for Disease Control and Prevention estimates that more than two-thirds of the world's population is infected with the bacterium, abbreviated H. pylori, but most infected people never have symptoms, the FDA said.
The BreathTek UBT test was newly approved based on results from a multi-location clinical trial involving 176 children, the agency said.
The test is produced by Otsuka America Pharmaceutical, headquartered in Rockville, Md.
To learn more about H. Pylori, visit the CDC.
Posted: February 2012
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