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CardioGenics Selects Clinical Test Sites for Its High Speed Portable Blood Analyzer

Mon, 06/21/2010 - 6:33am
Bio-Medicine.Org

MISSISSAUGA, Ontario, June 21 /PRNewswire-FirstCall/ -- CardioGenics Holdings Inc. (OTC Bulletin Board: CGNH), developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

The QL Care™ Analyzer will be tested utilizing CardioGenics' Troponin-I test, the first in a series of four cardiovascular tests to be offered for use with the QL Care™ Analyzer. Troponin-I, a protein marker released into the blood by dying heart tissue, definitively confirms that a heart attack is in progress.

The four selected sites – two are in the US and two are in Canada -- are active hospital emergency rooms that routinely admit patients presenting with chest pains.  Blood samples will be drawn from approximately 50 patients at each site.  One portion of each sample will be run on the hospital's central lab analyzer and the other on a CardioGenics QL Care™ Analyzer installed at the site.

The results will be compared. The goal is to confirm that the results from the CardioGenics QL Care™ Analyzers and the central lab systems are the same. The head-to-head confirmation tests will commence during Q3, upon approval of the Institutional Review Boards, and take approximately 45 days to complete.

Upon successful completion of clinical confirmation, the Company will then finalize protocols and commence trials for the FDA application for approval of its POC analyzer and Troponin-I test. The testing is expect

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