Evolution of Translational Omics:
Evolution of Translational Omics:
Evolution of Translational Omics:
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Evaluation for Clinical Utility and Use Phase• Clinical Utility: “Evidence <strong>of</strong> improved measurable clinicaloutcomes . . . compared with current management without[omics] testing.”• Clinical utility is not assessed by FDA or in the LDT process;utility is assessed in clinical trials and in decisions forreimbursement• Lack <strong>of</strong> FDA review does not mean lack <strong>of</strong> clinical utility• Process <strong>of</strong> gathering evidence to support clinical use shouldbegin before test is introduced into clinical practice
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