MISSISSAUGA, Ontario,
June 5, 2013 /PRNewswire/
-- CardioGenics Holdings Inc. (OTCBB: CGNH), developer of the
ultra-sensitive QL Care™ analyzer, an immunoassay Point-Of-Care
Analyzer, and other products targeting the
In-Vitro-Diagnostics testing market, announced today that it
has received approval of its clinical testing protocol from the
Institutional Review Board of Wayne State
University ("IRB"), which approval now enables the Company
to commence beta-site testing of its QL Care™ Analyzer and first
cardiovascular test, Troponin-I.
The beta-site testing will initially take place in hospitals
affiliated with Wayne State University
in Michigan. The Company is
currently working with the university to schedule the commencement
of beta-site testing. In accordance with the approved clinical
testing protocol, the trial is targeting to enroll approximately
200 patients whose blood samples will be analyzed by the QL Care™
Analyzer and its disposable self-metering test cartridge.
The purpose of the beta-site testing program is to test the QL
Care™ Analyzer and its first cardiovascular test, Troponin-I, in a
real world hospital setting in order to (a) document the
performance of the QL Care™ Analyzer and the Company's Troponin-I
test in such setting and (b) establish that its performance is
equivalent to that of the Siemens ADVIA Centaur XP lab-based
immunoassay analyzer (the "Siemens Centaur XP").
Once beta-site testing is complete and the results have been
analyzed, the Company will make any final adjustments that may be
necessary and then conduct the final clinical testing, also in a
hospital setting, the results of which will form the basis of the
Company's 510K application to the FDA, as well as its corresponding
application in the European Union for commercializing the QL Care™
Analyzer and Troponin-I test. The Siemens Centaur XP will also be
the predicate device against which the Company will compare the
performance of its QL Care™ Analyzer and Troponin-I test in these
final clinical tests.
"We are very excited to have received approval of the IRB of
Wayne State University to commence
beta-site testing of our QL Care™ Analyzer and Troponin-I test in
its affiliated hospitals," said Dr. Yahia
Gawad, CEO of CardioGenics. "We look forward to documenting
that our ultra-sensitive QL Care™ Analyzer can deliver at the
point-of-care, and in a 15-minute time frame, 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 Point-Of-Care 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 platform 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.
SOURCE CardioGenics Holdings Inc.