Evolution of Translational Omics:

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Big PictureRecommendations to ensure adoption of andadherence to the development and evaluation process• Investigators and institutions are responsible for the scientificculture in which omics-based tests are developed.• Recommendations are not intended to create new barriers,but rather to maintain the integrity of the scientific process.
Recommendation 4: Institutions4a: Institutions are responsible for establishing, supporting, andoverseeing the infrastructure and research processes foromics-based test development and evaluation.4b: Institutional leaders should promote a culture of integrity andtransparency by designating officials responsible for:i. IDE and IND requirementsii. Management of financial and non-financial conflicts ofinterest (individual and institutional)iii. A system for preventing, reporting, adjudicating lapsesin integrityiv. Establishing clear procedures for response to inquiries
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 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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