Healthcare Industry News: U.S. Food and Drug Administration
News Release - March 13, 2018
Exalenz Bioscience’s BreathID(R) Hp & BreathID Hp Lab Systems Receive FDA Clearance for Diagnosis of Helicobacter pylori Testing in Pediatric PatientsImportant new testing option for an infection that impacts nearly 20 million U.S. children and may have significant negative impacts on long-term health
MODI'IN, Israel and MANASQUAN, N.J., March 13, 2018 -- (Healthcare Sales & Marketing Network) -- Exalenz Bioscience Ltd. (TASE:EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, 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,  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.
“Exalenz Biosciences is committed to playing a leading role in reducing the negative health effects and costs associated with H. pylori infection, and the FDA clearance of the BreathID Hp test for use in pediatric patients allows us to expand that role,” said 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. 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 entry errors that could lead to incorrect results. 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.”
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.
About Exalenz Bioscience
Exalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company’s flagship BreathID® Hp offers the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. The BreathID 13C-methacetin breath test (MBT) is a sensitive, noninvasive, point of care tool that measures the microsomal function of the liver. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform, including MBT in the detection of CSPH in patients with NASH. Additional information is available at www.exalenz.com.
1 US Census Bureau, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk.
2 StaatMA, Kruszon-Moran D, McQuillan GM, KaslowRA. 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. http://jid.oxfordjournals.org/Content/174/5/1120.full.pdf.
3 Centers of Disease Control and Prevention, Helicobacter pylori and Peptic Ulcer Disease: The Key to Cure, https://www.cdc.gov/ulcer/keytocure.htm.
Source: Exalenz Bioscience
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