Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers June 22, 2018
Pharmacy Choice - Pharmaceutical News - Exalenz Bioscience's BreathID Hp & BreathID Hp Lab Systems Receive FDA Clearance for Diagnosis of Helicobacter pylori Testing in Pediatric Patients - June 22, 2018

Pharmacy News Article

 3/13/18 - Exalenz Bioscience's BreathID Hp & BreathID Hp Lab Systems Receive FDA Clearance for Diagnosis of Helicobacter pylori Testing in Pediatric Patients

MODI'IN, Israel and MANASQUAN, N.J., March 13, 2018 (GLOBE NEWSWIRE) 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, [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.

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 BreathIDHp 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.

Contact Information
Investor Relations
David Carey
212-8671768
dcarey@lazarpartners.com

Media
Glenn Silver
646-871-8485
gsilver@lazarpartners.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 Ltd.


2018 GlobeNewswire, Inc.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Jun 22: Telepharmacy- Remote Delivery of Pharmacy Services
Jun 24: Adverse Drug Events: Risk Reduction & Documentation
Jun 25: Management of Alcohol Use Disorders
Jun 26: COPD Update for Pharmacy Professionals
Jun 27: Adult Immunizations: A Guide for Pharmacists, Techs & NPs
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2018 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415