Healthcare stakeholders increasingly prioritize clinical utility in evaluating molecular diagnostics. Demonstrating this utility is crucial for diagnostics developers to secure payer acceptance and avoid business failure, as seen with Predictive Biosciences' CertNDx test. Clinical validation alone often isn't sufficient. Trials must bridge test results to improved health outcomes, requiring precise planning and meticulous execution. Ten key tips for establishing clinical utility include early planning, defining intended use, understanding decision contexts, assessing evidence linkages, identifying surrogate endpoints, and managing variability in physician decision-making and patient compliance.

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