Application for IRB Approval Submitted
posted on
Dec 20, 2011 12:12PM
Paramagnetic Beads and QL Analyser are Proprietary Products
CGNH issued the following Press Release today -
MISSISSAUGA, ON, Dec. 20, 2011 /CNW/ - CardioGenics Holdings Inc. (OTCBB: CGNH.OB - News), a leading In Vitro diagnostics company focused on cardiovascular testing products for the POC market, announced today that its application for Institutional Review Board (IRB) approval of its beta site testing protocol for the Company's QL Careā¢ Analyzer and Troponin-I cardiovascular test has been submitted.
Once the Company receives IRB approval, it will commence beta testing of its QL Care Analyzer and Troponin-I test at selected hospitals covered by the IRB approval.
"This study is a crucial step in confirming our current laboratory data from the QL Care Analyzer in a clinical setting," said Dr. Yahia Gawad, CEO of CardioGenics. "The findings will support our path towards the FDA submission. We will provide an update on the QL Care beta testing process, once it has been approved."
Finally CGNH has informed us they are using a Regional IRB to obtain permission to study the POC Analyzer and Troponin 1 cartridge. In my experience such an IRB will act on the application within 4-6 weeks. CGNH could announce patient recruitment has begun in mid to late January or early February of 2012.
Interesting that CGNH did not confirm that the study would be conducted in four separate hospitals using the Siemens equipment.
Ante