Exalenz Bioscience Ltd, Modi’in, Israel, has received FDA clearance for its BreathID Hp point-of-care system and BreathIDHp lab system for use in detecting Helicobacter pylori (H. pylori) bacteria in children aged 3 to 17 years.

Previously, the company’s BreathIDHp point-of-care system received FDA clearance for use in detecting H. pylori infections in adults in 2013, and the BreathID Hp lab system received similar clearance in November 2016. Exalenz also holds a 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 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, and significantly increases the risk of gastric cancer.2 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 effects for other members of the household.

“Exalenz Biosciences is committed to playing a leading role in reducing the negative health effects and costs associated with H. pylori infection, and FDA clearance of the BreathID Hp test for use in pediatric patients allows us to expand that role,” says Raffi Werner, chief executive officer of Exalenz Bioscience. “In today’s healthcare economic environment, there is a growing need to reduce cost and increase efficiency while providing high-quality care.”

Werner adds, “We believe that our ability to deploy the BreathID Hp test in the pediatric market will create value for physicians, children, their families, and our investors.”

FDA’s clearance for 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.

For more information, visit Exalenz Bioscience.

REFERENCES

  1. Staat MA, Kruszon-Moran D, McQuillan GM, et al. A population-based serologic survey of Helicobacter pylori infection in children and adolescents in the United States. J Infect Dis. 1996;174(5):1120–1123. Available at: http://jid.oxfordjournals.org/Content/174/5/1120.full.pdf.
  1. Helicobacter pylori and peptic ulcer disease: the key to cure [online]. Atlanta: Centers for Disease Control and Prevention, 2006. Available at: www.cdc.gov/ulcer/keytocure.htm. Accessed April 30, 2018.