FIGURE 3-4a. Mock label for a biomarker test directing molecularly targeted therapy for leukemia.

FIGURE 3-4aMock label for a biomarker test directing molecularly targeted therapy for leukemia

a Analytic Validity, or the accuracy of a test to detect the specific entity that it was designed to detect.

b Clinical Validity, or the accuracy of a test for disease diagnosis or predicting response to specific drug therapy.

c Ratings indicate:

****: Single source criteria provided;

****: Multisource consistency;

****: Expert panel consensus;

****: Practice guideline.

d Clinical Utility, or evidence of improved measurable clinical outcomes, usefulness, or added value.

From: 3, Supportive Policy Environment for Biomarker Tests for Molecularly Targeted Therapies

Cover of Biomarker Tests for Molecularly Targeted Therapies
Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine.
Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies; Board on Health Care Services; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine; Graig LA, Phillips JK, Moses HL, editors.
Washington (DC): National Academies Press (US); 2016 Jun 30.
Copyright 2016 by the National Academy of Sciences. All rights reserved.

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