Assay Development
Assay Development
CAVΛDIS™ 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.
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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. CAVΛDIS™ evaluates each marker in terms of predictive power, added value to existing risk scores, sensitivity, specificity and cost-effectiveness. CAVΛRISK ASSAYS™ are developed according to US and EU regulatory guidelines.