CardioGenics, a developer of technology and products targeting the in-vitro diagnostics segment of the Point-of-Care (PoC) diagnostic market, has completed the design of the self-metering cartridge for its PoC diagnostic device, QL Care Analyzer. The company has also filed a patent application regarding the self-metering cartridge.
With the completion of the design of the self-metering cartridge, a limited production run will be released, which will enable the company to adapt its first cardiovascular test, Troponin-I, to the self-metering cartridge. Troponin-I is a much-needed test that diagnoses the presence and severity of a heart attack, said the company.
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 required data regarding the performance of the QL Care Analyzer and the Troponin-I test, which will form the basis of the company’s 510K application to the FDA.
In addition to opening the door for commencement of beta-site testing, the self-metering cartridge also gives the company potential to selectively license its proprietary cartridge design to other POC device providers.
Yahia Gawad, CEO of CardioGenics, said: “The completion of the design of the self-metering cartridge is a major milestone in the development of our POC platform. 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.
“Importantly, the accuracy of testing will be improved. This ease of use, combined with the QL Care Analyzer’s lab quality sensitivity makes the QL Care Analyzer a unique and much needed offering in the POC diagnostic field.”