Evolution of Translational Omics:
Evolution of Translational Omics:
Evolution of Translational Omics:
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Recommendation 2: Test Validation• Test should be discussed with FDA prior to validationstudies.• Test development and validation should be performed in aCLIA-certified clinical laboratory.• CLIA lab should design, optimize, validate, and implementthe test under current clinical laboratory standards.• Analytical validation and CLIA requirements should be metby each laboratory in which test will be performed.