Exalenz Bioscience Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared the BreathID® Hp point-of-care system and the BreathID®Hp Lab system for use in detecting Helicobacter pylori (H. pylori) bacteria in children ages 3-17 years. Exalenz Bioscience’s BreathID® Hp system received FDA clearance for use in detecting H. pylori infections in adults in 2013 and BreathID®Hp Lab system in November 2016. Exalenz also holds an NDA (new drug approval) for the 13C Urea substrate used in the test. It is estimated that nearly 20 million children 17 years of age or younger are infected with H. pylori.1, [2] Prolonged H. pylori infection, including untreated early childhood exposure to infection, may predispose individuals to chronic disease. H. pylori infection is the cause of 90% of duodenal ulcers and 80% of gastric ulcers,3 and significantly increases the risk of gastric cancer. Additionally, because H. pylori is transmitted via fecal-oral, gastro-oral or oral-oral routes, infections tend to cluster within families, increasing the risk of long-term health effectives for other members of the household. The FDA clearance in the pediatric indication is based on data from a clinical trial with the primary goal of confirming the safety of the 13C-urea substrate in pediatric subjects, and a secondary goal of assessing performance of the BreathID® Hp Systems compared to stool antigen testing. The BreathID Hp test result can be interpreted without the need for additional calculations, which makes it more efficient and user-friendly compared with competing tests approved for the pediatric market. Data from efficacy trials in adults show that the BreathID Hp point-of care test has 100% sensitivity and 99.2% specificity and the BreathID Hp Lab test has 100% sensitivity and 97.9% specificity, the most accurate systems approved by the FDA for the detection of H. pylori.