Approval clears the way for commencement of beta-site testing of the QL Care™
Analyzer in hospitals
MISSISSAUGA, Ontario – June 05, 2013 - 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.
