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FDA Clearance for Centralised Breath-test Diagnosis of H.pylori

Exalenz Bioscience has received U.S. Food and Drug Administration (FDA) marketing clearance for its BreathID® Lab System and breath-test kits, developed for detection of Helicobacter pylori.

The BreathID® Hp Lab System is based on measuring the level of change of 13C labeled urea in a patients breath and aims to facilitate H. pylori diagnosis, in a central location, of large numbers of breath samples that are collected and then delivered to the laboratory. At clinics and medical centers, the patient breathes into two designated collection bags and the breath samples are subsequently sent for analysis to central laboratories where the new system will be installed.

The BreathID® Hp Lab System can perform sequential diagnosis in a fully automated and undisrupted process, minimizing potential human error. This proprietary technology makes it possible to significantly increase the number of tests performed with optimal efficiency, without requiring the clinics where the samples are collected to purchase a specialized device.


     
Tags: Helicobacter pylori

Date Published: November 8, 2016

Source article link: Exalenz Bioscience » company contact details
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