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CardioGenics Selects Clinical Test Sites for Its High Speed Portable Blood Analyzer
Date:6/21/2010

ed to start during early Q4 2010 and complete two months later.

These results, if successful, will be filed with the U.S. Food and Drug Administration ("FDA") as part of a 510-K submission seeking approval to market the QL Care™ Analyzer and the Company's first cardiovascular test, Troponin-I. Based on FDA statistics for FY 2008, 510-K applications receive a final FDA decision in an average of 109 days from the date of submission.

The capability of the CardioGenics QL Care™ Analyzer to generate accurate Troponin test results in 15 minutes (vs. an average of 2.8 hours required for central labs machines) is expected to play a central role in emergency rooms where it holds the potential to significantly decrease the time required to triage chest pain patients -- accelerating treatment to the 15 percent of the patients who actually are having a heart attack, while avoiding unnecessary treatments for the 85 percent who aren't.

Troponin testing, which is standard protocol in the U.S. for anyone presenting with chest pains, is an estimated $650 million test reagent market, predominantly served by tests performed in large central hospital labs.

The Company expects to enter into distribution agreements, in the U.S. and abroad, for the sale of the QL Care™ Analyzer and consumable reagent cartridges for its approved tests.

Further information regarding the QL Care™ Analyzer and CardioGenics' battery of cardiovascular tests is available at the Company's website (www.cardiogenics.com). A new "Company Profile" is also available at:


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SOURCE CardioGenics Holdings Inc.
Copyright©2010 PR Newswire.
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