FDA approves H. pylori breath test for children
The FDA has expanded indications for a breath test that detects Helicobacter pylori, a bacterium responsible for gastritis and ulcers, making it the first of it's kind approved for use in children aged 3 to 17 years.
The CDC estimates approximately two-thirds of the world's population are infected with H. pylori, but most never experience symptoms. Despite many being asymptomatic, those infected have a two- to six-fold increased risk for gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with those free of infection.
“Results from this test, when considered with a clinician'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, of the FDA's Center for Devices and Radiological Health said in a press release.
BreathTek UBT (Otsuka America Pharaceutical) was first approved for use in adults in 1996 and received approval for the expanded pediatric indication after a multi-center clinical trial involving 176 patients demonstrated the test had 95.8% sensitivity and 99.2% specificity.
Data from an additional study performed in the one to six months post treatment indicated the test had 83.3% sensitivity and 100% specificity.