CardioGenics Announces Schedule for Beta-Site Testing
July 10 2013 - 8:00AM
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.
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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