CardioGenics Holdings Inc. announced that it has commenced beta-site testing of its QL Care(TM) 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(TM) 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(TM) Analyzer and Troponin-I test. The company currently anticipates final clinical testing to commence during fourth quarter of 2013.

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'). The company 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.