MISSISSAUGA, Ontario, July 10, 2013 (GLOBE NEWSWIRE) -- CardioGenics Holdings Inc. (OTCBB:CGNH), developer of the ultra-sensitive QL Care™ analyzer, an immunoassay Point-Of-Care analyzer, and other products for the In-Vitro-Diagnostics testing market, announced today that beta-site testing of its QL Care™ Analyzer and Troponin-I test is scheduled to commence at hospitals affiliated with Wayne State University during the month of July 2013. The Company expects this testing program to be completed within 8-12 weeks.
In accordance with the approved testing protocol, blood samples from approximately 200 patients presenting with chest pain will be analyzed by both the QL Care™ Analyzer and the Siemens ADVIA Centaur XP, a central laboratory-based immunoassay analyzer (the "Siemens Centaur XP"). The Troponin-I testing results of the samples analyzed by both devices will be compared in order to document the "equivalence" of the QL Care™ Analyzer and its Troponin-I test.
Following completion of the beta-site testing program, the Company will make any final adjustments to the QL Care™ Analyzer and Troponin-I test that may be necessary and then conduct the final clinical testing, the results of which will form the basis of the Company's 510(K) application to the FDA, as well as its corresponding application in the European Union for commercialization of the QL Care™ Analyzer and Troponin-I test.
"We look forward to documenting the performance of our ultra-sensitive QL Care™ Analyzer and its Troponin-I test in comparison to the Centaur XP central lab analyzer, said Dr. Yahia Gawad, CEO of CardioGenics. "We are confident that our ultra-sensitive QL Care™ Analyzer will be able to deliver at the point-of-care, and within 15-minutes, the test sensitivity that, to date, has only been possible by using lab-based analyzers," continued Dr. Gawad.
ABOUT CARDIOGENICS HOLDINGS INC.
Through its operating subsidiaries, the Company develops ultra-sensitive analyzers and other products targeting the immunoassay segment of the IVD testing market. It has developed the QL Care™ Analyzer, a proprietary and ultra-sensitive Point-Of-Care immuno-analyzer, which will run a number of diagnostic tests under development, the first of which will be a series of cardiovascular diagnostic tests. As part of its core proprietary technology, the Company has also developed a proprietary method for silver coating paramagnetic microspheres (a fundamental component of immunoassay equipment), which improve instrument sensitivity to light. The Company's proprietary microspheres technology and SAVAsphere™ magnetic beads are developed and marketed through the Company's Luxspheres subsidiary. The Company's principal offices are located in Mississauga, Ontario, Canada. For more information please visit www.cardiogenics.com and www.luxspheres.com.
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