CardioGenics Holdings Inc announced the selection of four sites for clinical testing of its patented QL Care™ analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.
The QL Care™ analyzer will be tested utilizing CardioGenics’ Troponin-I test, the first in a series of four cardiovascular tests to be offered for use with the QL Care Analyzer. Troponin-I, a protein marker released into the blood by dying heart tissue, definitively confirms that a heart attack is in progress.
The four selected sites – two are in the US and two are in Canada—are active hospital emergency rooms that routinely admit patients presenting with chest pains. Blood samples will be drawn from approximately 50 patients at each site. One portion of each sample will be run on the hospital’s central lab analyzer and the other on a CardioGenics QL Care analyzer installed at the site.
The results will be compared. The goal is to confirm that the results from the CardioGenics QL Care analyzers and the central lab systems are the same. The head-to-head confirmation tests will commence during Q3, upon approval of the Institutional Review Boards, and take approximately 45 days to complete.
Upon successful completion of clinical confirmation, the company will then finalize protocols and commence trials for the FDA application for approval of its POC analyzer and Troponin-I test. The testing is expected to start during early Q4 2010 and complete two months later.
These results, if successful, will be filed with the FDA as part of a 510-K submission seeking approval to market the QL Care analyzer and the Company’s first cardiovascular test, Troponin-I. Based on FDA statistics for FY 2008, 510-K applications receive a final FDA decision in an average of 109 days from the date of submission.
The capability of the CardioGenics QL Care analyzer to generate accurate Troponin test results in 15 minutes (vs an average of 2.8 hours required for central labs machines) is expected to play a central role in emergency rooms where it holds the potential to significantly decrease the time required to triage chest pain patients—accelerating treatment to the 15 percent of the patients who actually are having a heart attack, while avoiding unnecessary treatments for the 85% who aren’t.
The Company expects to enter into distribution agreements, in the US and abroad, for the sale of the QL Care analyzer and consumable reagent cartridges for its approved tests.
Source: CardioGenics Holdings
