FDA Clears New H. pylori Testing Option for Pediatric Patients
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.
For more information visit Exalenz.com.