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.
Recommendation 3: Evaluation for Clinical Utilitya. Investigators should communicate early with the FDAregarding Investigational Device Exemption (IDE) process.b. <strong>Omics</strong>-based tests should not be changed during theclinical trial without a protocol amendment and discussionwith the FDA. A substantive change to the test may requirerestarting study.
Page 1 and 2: Evolution of Translational Omics:Le
Page 3 and 4: Disclosure Information:Name of Spea
Page 5 and 6: Origin of the Task for the IOM Comm
Page 7 and 8: IOM Committee Composition20 member
Page 9 and 10: Omics• Encompasses multiple molec
Page 11 and 12: Omics-Based Test DevelopmentFramewo
Page 13 and 14: How are Omics Tests Different?• N
Page 15 and 16: Discovery Phase• Candidate test i
Page 17 and 18: Test Validation Phase
Page 19 and 20: How are Omics Tests Different?• R
Page 21 and 22: Evaluation for Clinical Utility and
Page 23 and 24: Case Studies (see report appendix)
Page 25 and 26: Statistical and Bioinformatics Vali
Page 27: Disclosure Information:Name of Spea
Page 34 and 35: ClinicalTrials.gov ID NCT00636441 N
Page 36 and 37: Importance of:Lessons from the Duke
Page 40 and 41: Big PictureRecommendations to ensur
Page 42 and 43: Recommendation 4: Institutions4c: I
Page 44 and 45: Recommendation 6: FDA6a: FDA should
Page 46 and 47: AcknowledgementsStudy Funders:Natio
Page 48 and 49: To download or read the report onli
Page 50 and 51: HER 2 Early single marker test for
Page 52 and 53: MammaPrint 70 gene microarray expre
Page 54 and 55: OvaCheck Serum proteomics-based app
Page 56 and 57: Allomap Blood test; measures expres

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