February 1, 2010 – The design have been completed and a patent application filed for a troponin-I self-metering cartridge for the QL Care Analyzer point-of-care (POC) diagnostic device. The system does not require a lab technician. Troponin-I is used to diagnose the presence and severity of a heart attack.
“The completion of the design of the self-metering cartridge is a major milestone in the development of our POC platform,” said Yahia Gawad, CEO of the device maker CardioGenics. “The self-metering cartridge provides our QL Care Analyzer with unprecedented ease of use for a POC diagnostic device, allowing tests to be run on the device by laypersons instead of expensive lab technicians. More importantly, the accuracy of testing will be tremendously improved.”
CardioGenics anticipates receiving the limited production run of the self-metering cartridges during February 2010. Adaptation of the troponin-I test to the self-metering cartridge, along with preparations for beta-site testing, will then follow leading up to the anticipated commencement of beta-site testing in mid-2010 at hospitals and laboratories identified by the company. Beta-site testing will provide the company with the required data regarding the performance of the QL Care Analyzer and the troponin-I test, which will form the basis of the company's 510(k) application to the FDA.
For more information: www.cardiogenics.com