A tiered approach to integrating genomic tests into

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A tiered approach to integrating genomic tests into

  1. 1. A Tiered Approach toIntegrating Genomic Tests Into Your Practice
  2. 2. DefinitionTiered Approach: TypesGenomic Tests: DNA screening testPractice: Giving a diagnosis and prescribing atreatment for medical conditionCombine DNA screening with medical treatmentto test the probability of certain disease.
  3. 3. InitiationOffice of Public Health Genomics at the Centersfor Disease Control and Prevention (CDC)
  4. 4. A New EraMedicine informed by new "personalization"tools in diagnosis, management, and preventionof many diseases of public health significance.However,The mere availability of a health applicationdoes not necessarily imply evidence of efficacy.
  5. 5. the CDC Office of Public Health Genomics hasrecently created an evolving list of health-related genomic tests and family health historyapplications 3 Tier
  6. 6. 1st Tier
  7. 7. 1st TierApplications are recommended for clinical useby evidence-based panels and are supported bya systematic review of evidence establishing thevalidity and utility of these tests for theirintended use.
  8. 8. • Newborn screening• BRCA1 and BRCA2• Colorectal cancer surveillance
  9. 9. • evidence-based recommendation from the Evaluation of Genomic Applications in Practice and Prevention (EGAPP)http://www.egappreviews.org/recommendations/index.htm
  10. 10. 2nd Tier
  11. 11. 2nd TierApplications have evidence establishing validityand promising utility, but they lack evidence-based recommendations for their use, orevidence-based panels have simply foundinsufficient evidence.
  12. 12. • pharmacogenomic testing individualization of the choice or dose of a drug.• Family history of Diabetes Mellitus
  13. 13. 3rd TierGenomic and family health history applicationshave not demonstrated adequate analyticvalidity, clinical validity, or clinical utility.
  14. 14. Such applications are not ready for routinepractice but may be considered in clinical andpopulation research.• whole genome sequencing/next-generation sequencing
  15. 15. Summary"personalization“PreventionẊ ready for "prime time.“Ẋ Lack of evidence
  16. 16. Web ResourcesCDC. Public Health Genomics. Genetic TestingCDC. Tier 1 Genomic and Family Health History Applications.CDC. Tier 2 Genomic and Family Health History Applications.CDC. Tier 3 Genomic and Family Health History Applications.
  17. 17. Michael Scott BowenScott Bowen is the deputy director of the Office of Public HealthGenomics.He earned his Masters of Public Health degree in Epidemiology from TulaneUniversity.Mr. Bowen came to CDC under the Outstanding Scholar Program in 1992 andhad previously served on active duty as a non-commissioned officer with theU.S. Army. His past CDC roles included service as the Management Officer forthe CDC/OD offices and as the deputy director for the Division of PublicHealth Surveillance and Informatics. He has also worked for the Agency forToxic Substances and Disease Registry where he served as an epidemiologistand as deputy chief of the Health Investigations Branch.
  18. 18. Thank you

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