Evolution of Translational Omics:

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Lessons Learned From Case StudiesKeys to a successful case study:• A well-designed development plan• Data and code availability• Separate discovery and validation sets• Lock down prior to clinical validation and use of test• Interaction with the FDA• Assessment of clinical utility• Oversight by investigators and institution
Statistical and Bioinformatics ValidationTest Lockdown Reported? Overlap of Discovery andValidation Datasets at SomePoint in Test Development?Oncotype DX Yes (Paik et al., 2004) NoMammaPrint Yes (Personal communication) a YesTissue of OriginYes (Monzon et al., 2009; Pillai etal., 2011; personal communication) bNoOVA1 Yes (Personal communication) c NoAlloMap Yes (Personal communication) d YesCorus CAD Yes (Rosenberg et al., 2010) NoaLaura van‘t Veer, November 28, 2011bEd Stevens, Pathwork Diagnostics, October 18, 2011cScott Henderson, Vermillion, December 12, 2011dMitch Nelles, XDx, October 12, 2011
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: Case Studies (see report appendix)
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 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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