Otsuka America receives FDA nod for breath test in children
The first breath test to detect Helicobacter pylori bacterial infections in children.
Mon, Feb 27, 2012 at 11:48 AM
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.
Copyright 2012 Reuters U.S. Online Report Health News