Evolution of Translational Omics:

More documents

Recommendations

Info

Theranostics and Personalized MedicineTheranostics combines molecularly targeted therapies withcompanion diagnostics to stratify and identify patients forwhom the targeted therapy will be most appropriate.The diagnostics are likely to be based on, or informed by,multi-analyte molecular signatures.
Origin of the Task for the IOM Committee• Omics tests developed at Duke to predict sensitivity to chemoRx• Papers in 2006/2007 suggested major advance in directing therapy• Concerns about accuracy and validity were raised immediately and in2009 Annals of Applied Statistics publication by Baggerly and Coombes:‣ Numerous errors in test development‣ Inconsistencies between primary data and data used in articles‣ Failure to reproduce results• Criticisms rebuffed for 4 years while:• Hundreds of publications cited papers in question• 2 companies launched• 3 Clinical trials initiated in 2007, using tests to direct patient care• Trials scrutinized by NCI statistical staff, but apparently not byfunders or general oncologic scientific community• 2010 letter to director of NCI, signed by more than 30bioinformaticians and statisticians, urged suspension of trials• IOM asked to review situation and provide guidance for the field
Page 1 and 2: Evolution of Translational Omics:Le
Page 3: Disclosure Information:Name of Spea
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 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
show all

Evolution of Translational Omics:

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?