FIGURE 4-1 Omics-based test development process, highlighting the evaluation for clinical utility and use stage. The bright line signifies the point in test development where a fully defined, validated, and locked-down clinical test is necessary. Changes to the test after the bright line is crossed require going back to the test validation phase, approval by the IRB, and possibly consultation with FDA. In this stage of test development and evaluation, the fully defined and validated omics-based test undergoes evaluation for clinical use. Determination of clinical utility is a process that often occurs over a longer time frame. NOTE: FDA = Food and Drug Administration, IDE = investigational device exemption, IRB = Institutional Review Board, LDT = laboratory-developed test.