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Digestive Health

FDA approves breath test to determine bacterial infection in kids

U.S. health regulators have approved Otsuka America Pharmaceutical's breath test to detect bacterial infection that causes stomach inflammation and ulcer, for use in children aged 3 to 17 years.

A press release from the U.S. Food and Drug Administration said BreathTek UBT was the first breath test to detect Helicobacter pylori bacterial infections in children.

Rockville, Maryland-based Otsuka America, a unit of Japan's Otsuka Holdings Co Ltd, was granted approval to market its breath test for use in adults in 1996.

"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," the FDA release said.

U.S. Centers for Disease Control and Prevention estimate that about two-thirds of the world's population is infected with Helicobacter pylori, which increases the risk of developing gastric cancer and a type of lymphoma.

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