Monday, July 21, 2008

BreathID for Simple Liver Disease Identification Gets FDA's Trial OK

Filed under: Diagnostics , GI , Medicine

Here's a follow up on our post from April. The FDA has given Israel's Exalenz the go-ahead to proceed with Phase III clinical trial to test the company's BreathID system for diagnosing liver disease. The device uses something called Molecular Correlation Spectroscopy which uses 12CO2 and 13CO2 discharging lamps to detect the ratio of carbon 12 and carbon 13 isotopes.

The trial will include 412 patients at 12 large medical centers in the US as well as at Hadassah Medical Organization in Jerusalem. Exalenz says that it believes that this is the largest clinical trial of its kind ever conducted by an Israeli company. The trial aims at replicating the results of the Phase II clinical trial in Israel and Europe, which was completed a few months ago.

Here's a video overview of the BreathID system:

Press release: FDA approves Exalenz Liver Trial (.pdf)...

BreathID technology page...

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