CardioGenics Announces Commencement of Beta-Site Testing
21 Août 2013 - 3:00PM
Beta-Site Testing of the Company's QL
Care™ Analyzer and Troponin-I Test Begins in Two Hospitals
CardioGenics Holdings Inc. (OTCBB:CGNH), developer of the QL Care™
analyzer, an ultra-sensitive immunoassay point-of-care analyzer,
and other products targeting the In-Vitro-Diagnostics testing
market, announced today that it has commenced beta-site testing of
its QL Care™ Analyzer and first cardiovascular test, Troponin-I.
The beta-site testing was commenced in two hospitals affiliated
with Wayne State University.
In accordance with the approved testing protocol, blood samples
from approximately 200 patients presenting with chest pain will be
analyzed for Troponin I by both the QL Care™ Analyzer and the
Siemens ADVIA Centaur XP, a central laboratory-based immunoassay
analyzer. The test results of the analyzed samples will be compared
in order to document the "equivalence" of both devices. The Company
expects beta-site testing to be completed within 10-12 weeks.
The results of this pilot testing 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. The
Company currently anticipates final clinical testing to commence
during Q4 of 2013.
"We look forward to obtaining our beta-site testing results so
we can demonstrate that our QL Care™ Analyzer can deliver
Troponin-I results within 15 minutes at the point-of-care, with the
test sensitivity that, to date, has only been possible by using
lab-based analyzers that take significantly longer than 15 minutes
to provide results," said Dr. Yahia Gawad, CEO of CardioGenics.
"With its ultra-sensitivity, and fast and accurate test results,
the QL Care™ Analyzer is well positioned to remove the current
limitations of point-of-care immunoassay testing, thereby improving
patient outcomes and reducing the costs associated with such
healthcare," continued Dr. Gawad.
Troponins are considered the "gold-standard" cardiac biomarkers
for the diagnosis and management of myocardial infarctions (heart
attack). The average time to deliver Troponin results across the
U.S. is currently estimated to be 2.8 hours, which falls far short
of the American Heart Association's guidelines for obtaining
Troponin test results within sixty minutes (the so-called "Golden
Hour"). CardioGenics intends to change this dynamic by not only
providing lab-quality Troponin test results within 15 minutes but
also by providing such results directly to the point-of-care at a
significantly reduced cost, resulting in quicker and more effective
treatment of patients presenting with chest pain and, ultimately,
saving lives and significantly reducing related healthcare
costs.
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.
CONTACT: CardioGenics Holdings Inc.
Joseph J. Nese
Tel: 1.516.428.4200
CardioGenics (CE) (USOTC:CGNH)
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