Acceptance of biomarker-based tests for application in clinical practice: criteria and obstacles

The journey from the discovery of a biomarker to its implementation in clinical practice is long and complex. There are many obstacles along the way, including lack of consistent evidence, inadequate validation of the biomarker, inadequate evidence of clinical utility, operational barriers to clinical implementation, and inadequate evidence of operational effectiveness or impact in clinical care. Multipronged approaches, incorporating input from many disciplines working together, will be required to overcome the obstacles to the clinical implementation and to allow the progression of clinical practice from the current paradigm of a one-size-fits-all strategy to more personalized treatment pathways that are more predictable in terms of health gains.