Monday, December 14, 2009

Let's Smell Your H. pylori! BreathID Racks Up New Positive Trial on Road to FDA Approval

Filed under: GI

Globes [online], Israel's business newspaper, is reporting that Exalenz out of Modiin, Israel has completed a clinical trial testing its BreathID system for detection of Helicobacter pylori bacteria in patients' breath. According to the company, the trial involved 167 patients and the system was 99.2% accurate when compared to isotope ratio mass spectrometry (IRMS). Exalenz is hoping this will help it obtain FDA regulatory approval to market the device in the U.S.

Some details about how the system works:

BreathID uses a clinically proven, sophisticated laser-like light source to pinpoint real-time changes in 13C/12C isotope ratios at an accuracy level of single parts per million. It is a paradigm change in the way liver and GI disorders are assessed and managed. Covered by more than 60 patents and patent applications worldwide, the BreathID system is one of the most versatile and advanced diagnostic platforms for hepatologists and gastroenterologists in today`s medical environment.

BreathID® is a proven, breath-testing system that incorporates a number of proprietary core technologies - such as Microstream®, MCS™ (Molecular Correlation Spectroscopy), CRT™ (Continuous Real Time) and online analysis algorithms that are protected by a series of patents and patent applications.

The BreathID combination of advanced technologies allows for automatic, continuous and real-time breath sampling and analysis. This ensures highly accurate results and the shortest possible test duration. Moreover, the system is portable so that tests can be conducted in any clinical setting.

BreathID Technology Process:

Here are a couple videos explaining the BreathID system and demonstrating its use:

Product page: BreathID System...

Globes [online]: Exalenz reports trial success for breath test bacteria detector...

Original Hebrew press release...

Flashbacks: BreathID for Simple Liver Disease Identification Gets FDA's Trial OK; BreathID Sniffs Success, Eyes FDA Approval; BreathID for Simple Liver Disease Identification Gets FDA's Trial OK

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