FDA Clears New H. pylori Testing Option for Pediatric Patients

Helicobacter pylori
Helicobacter pylori
The result comparisons found an overall agreement in the pre-therapy cohort between the breath test and the reference biopsy result of 98.3% (95 CI: 95.2%-99.7%).

The Food and Drug Administration (FDA) has cleared the BreathID Hp point-of-care system and the BreathID Hp Lab system (Exalenz) for use in detecting Helicobacter pylori (H. pylori) bacteria in children aged 3 to 17 years. 

BreathID Hp technology is based on measuring the level of change of 13C labeled urea detectable in a patient’s breath. This is measured before and after the ingestion of a low dosage of 13C labeled urea dissolved in water or orange juice. Unlike other urea breath tests, BreathID Hp is performed in real-time. The patient’s breath is sampled continuously and automatically, eliminating the need for sample collection, labeling, transport and analysis stages. 

Approval for the pediatric indication was based on data from a study which assessed the safety of the 13C-urea substrate (primary endpoint) and performance of the BreathID Hp Systems (secondary endpoint) in pediatric subjects compared to stool antigen testing. 

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