On Feb. 22, the FDA approved the BreathTek UBT breath test for use in children aged 3 to 17 years to detect Helicobacter pylori bacterial infection. The test, manufactured by Otsuka America Pharmaceutical, is a noninvasive urea breath test to diagnose and monitor H. pylori infection, and was approved by the FDA for 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, which allows a physician to initiate appropriate health measures in a timely manner,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA based its approval of the breath test on a multicenter study of 176 children, which showed the method had 95.8% sensitivity and 99.2% specificity when compared with a composite reference. In a follow-up study performed one to six months after therapy, researchers demonstrated the test’s efficacy in monitoring patients after treatment; the test achieved 88.3% sensitivity and 100% specificity.
—Based on a press release from the FDA