Cardiogenics is seeking FDA approval for the QL Care Analyzer and three additional tests in three-month intervals. Dr. Gawad explained, "as a first test, it will diagnose a heart attack quickly in those patients whose EKGs do not reveal clear evidence of one.
"The second test, the PIA-1 test, is a triage test for optimizing the performance of tPA, even though cardiac markers are not the indicators for administering tPA. Currently, the patient is diagnosed with a heart attack by means of the EKG and thereby becomes a candidate for tPA. The physician must decide whether the patient should be given tPA. Although the benefits of tPA are very clear, the failure rate is high. This new test is a treatment triage test.
"The third test product is the HFRS, which targets another group of patients -- those with heart failure. In 90% of heart failure cases, the patient had suffered a previous heart attack. This test paves the way toward the pre-selection of optimal treatment for heart failure patients, in contrast to the current trial and error approach.
"The logic behind these three tests is to diagnose those with no clear EKG evidence of heart attack, to triage those with clear evidence, and to assess biochemically the risk borne by those who have had a previous heart attack."
CardioGenics has also benefited from its agreement with Merck Chimie, S.A.S. concerning its paramagnetic beads utilized in the QLCA unit. Dr. Gawad said, "We approached all kinds of suppliers. Knowing that the product needed to be custom-built, we took the initiative to develop the beads in-house, and this was driven mainly by cost issues. We developed the beads and generated enough data to demonstrate their value. Merck Chimie, S.A.S. invited us to present our data at an international conference hosted by them, and we realized the commercial opportunity for the beads as a standalone product. We subsequently expanded on the data set and presented t
|SOURCE CardioGenics Holdings Inc.|
Copyright©2009 PR Newswire.
All rights reserved