CardioGenics, a developer of the ultra-sensitive QL Care Point-Of-Care (POC) analyzers in the in-vitro diagnostics market, has selected four clinical testing sites for its patented QL Care Analyzer. The analyzer is a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15minutes using whole blood.
The QL Care Analyzer will be tested utilising CardioGenics’ Troponin-I test, the first in a series of four cardiovascular tests to be offered for use with the QL Care Analyzer.
According to CardioGenics, out of the four selected sites two are in the US and the other two in Canada which are active hospital emergency rooms that routinely admit chest pain patients. 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.
CardioGenics said that the head-to-head confirmation tests are expected to commence during Q3, upon approval of the Institutional Review Boards, and take approximately 45 days to complete. The results when compared from the QL Care Analyzers and the central lab systems should be the same.
Upon completion of clinical confirmation, CardioGenics will then finalize protocols and commence trials for the FDA approval for its POC analyzer and Troponin-I test. The testing is expected to start during early Q4 2010 and complete two months later.
The 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 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, is expected to play a central role in emergency rooms where it holds the potential to decrease the time required to triage chest pain patients.
CardioGenics 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.