Evolution of Translational Omics:

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Recommendation 6: FDA6a: FDA should develop and finalize a risk-based guidance ora regulation on:i. Bringing omics-based tests to the FDA for reviewii. Oversight of LDTs6b: FDA should communicate IDE requirements for use ofomics-based tests in clinical trials to OHRP, IRBs, and others.
Recommendation 7: JournalsJournal editors should:7a: Require authors describing clinical evaluations of omicsbasedtests to:i. Register all clinical trialsii. Make data, metadata, analysis plans, code, and fullyspecified computational models publicly availableiii. Provide relevant sections of the research protocoliv. Require authors to state roles and attest to study integrityv. Use appropriate reporting guidelines7b: Develop mechanisms to resolve possible serious errors7c: Alert the institutional leadership and all authors when aserious question of accuracy or integrity has been raised
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 38 and 39: Recommendation 2: Test Validation
Page 40 and 41: Big PictureRecommendations to ensur
Page 42 and 43: Recommendation 4: Institutions4c: I
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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