FDA approves H. pylori breath test for children


The US Food & Drug Administration has approved the first breath test for use in children ranging in age between 3 and 17 for the detection of the Helicobacter pylori bacterial infection.

BreathTek UBT was first FDA approved for adults back in 1996. It was approved for children based on a published study involving 176 patients. The detector proved to have a 95.8 percent sensitivity rating.

In addition to being a culprit in causing gastritis and ulcers in the stomach, theHelicobacter pyloribacteria has also been implicated in some stomach cancers, notably in mucosal-associated-lymphoid-type (MALT) lymphoma, a mostly indolent for of B-lineage non-Hodgkin's lymphoma.

Source: FDA

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