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FDA approves first H. pylori breath test for children
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The FDA has approved the first breath test for use in children aged 3 to 17 years to detect Helicobacter pylori bacterial infections, responsible for gastritis and ulcers.
The FDA has based its approval of the BreathTek UBT test (Otsuka America Pharmaceuticals) for children on a multicenter study of 176 patients, evaluating its performance to a composite reference method that demonstrated 95.8% sensitivity and 99.2% specificity. A follow-up study was performed at 1 to 6 months after therapy to support use for post-treatment monitoring of patients, which exhibited 83.3% sensitivity and 100% specificity.
“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 the FDA’s Center for Devices and Radiological Health, said in a press release.
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