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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