DIS™ recognizes the increasing need for novel biomarkers to assess cardiovascular risk and acknowledges the rigourous requirements to prove their value in clinical practice. Recently the American Heart Association (AHA)
published a set of guidelines proposing standards for the critical appraisal of novel biomarkers.
For an adequate evaluation of novel biomarkers the study design should be representative for the at-risk population and an adequate number of cardiovascular adverse events must be reported. CAVΛ
DIS™ evaluates each marker in terms of predictive power, added value to existing risk scores, sensitivity, specificity and cost-effectiveness. CAVΛ
RISK ASSAYS™ are developed according to US and EU regulatory guidelines.