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Share Name | Share Symbol | Market | Type |
---|---|---|---|
CardioGenics Holdings Inc (CE) | USOTC:CGNH | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.000001 | 0.00 | 01:00:00 |
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.
Safe Harbor Statement - Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and may contain forward-looking statements, with words such as "anticipate, "believe," "expect," "future," "may," "will," "should," "plan," "projected," "intend," and similar expressions to identify forward-looking statements. These statements are based on the Company's beliefs and the assumptions it made using information currently available to it. Because these statements reflect the Company's current views concerning future events, these statements involve risks, uncertainties and assumptions. The actual results could differ materially from the results discussed in the forward-looking statements. In any event, undue reliance should not be placed on any forward-looking statements, which apply only as of the date of this press release. Accordingly, reference should be made to the Company's periodic filings with the Securities and Exchange Commission.
CONTACT: CardioGenics Holdings Inc. Joseph J. Nese Tel: 1.516.428.4200
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