Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics
In many cases, developers of molecular diagnostics can only ensure healthcare payer reimbursement and clinician adoption by demonstrating not only the analytic and clinical validity of their assays but also their clinical utility. This requirement holds despite the many steps and considerable time that often come between the utilization of test results and patient outcomes. Intervening steps include treatment decisions, actual treatment and, in many cases, variability in patient compliance. Health Decisions’ Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics – Stepping Stones to Precision Medicine describes techniques for identifying and executing the optimal strategy for establishing clinical utility. Topics addressed in the white paper include strategies for determining the need for a clinical trial to assess outcomes and, if such a trial is required, conducting it as efficiently as possible.