diaDexus moves CAD (coronary artery disease) risk test closer to the US:
This article was originally published in Clinica
Executive Summary
diaDexus is pushing ahead with efforts to market in the US its PLAC blood test for predicting coronary artery disease (CAD) risk, after submitting a 510(k) application for the product to the FDA. The test provides a quantitative measurement of lipoprotein-associated phospholipase A2, or Lp-PLA2, a marker believed to be a risk factor for coronary heart disease. Since a significant proportion of individuals who suffer a heart attack have no previous signs or symptoms of coronary heart disease, such as elevated cholesterol, there is clearly a need for additional tests to accurately identify those at risk, says Patrick Plewman, the San Francisco, California's firm's CEO.