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FDA Clears Two Exalenz Bio H. pylori Systems

NEW YORK (GenomeWeb) – The US Food and Drug Administration has cleared a point-of-care and a lab system from Exalenz Bioscience for detecting Helicobacter pylori bacteria in children between the ages of three and 17.

The two platforms, the BreathID Hp point-of-care system and the BreathID Hp Lab system, were previously cleared by the FDA for detecting H. pylori infection in adults. According to Exalenz, efficacy trials in adults have indicated that the BreathID point-of-care system has 100 percent sensitivity and 99.2 percent specificity, while the BreathID Hp Lab test has 100 percent sensitivity and 97.9 percent specificity.

The company noted that in the US about 20 million children under the age of 17 are infected with H. pylori.

"The BreathID Hp test, the most accurate H. pylori test on the market, does not require secondary calculations, making more efficient use of healthcare provider resources and eliminating the risk of data errors that could lead to incorrect results," Exalenz CEO Raffi Werner said in a statement.

During the summer, company officials told 360Dx that changes in guidelines could increase adoption of  Exalenz's H. pylori tests.

Based in Modiin, Israel, the company develops breath-based tests and monitoring systems for diagnosing and managing gastrointestinal and liver conditions.