a tiered approach to integrating genomic tests into

A Tiered Approach to Integrating Genomic Tests Into Your Practice

DefinitionTiered Approach: TypesGenomic Tests: DNA screening testPractice: Giving a diagnosis and prescribing a treatment for medical condition

Combine DNA screening with medical treatment to test the probability of certain disease.

InitiationOffice of Public Health Genomics at the Centers for Disease Control and Prevention (CDC)

A New EraMedicine informed by new "personalization" tools in diagnosis, management, and prevention of many diseases of public health significance.

However,

The mere availability of a health application does not necessarily imply evidence of efficacy.

the CDC Office of Public Health Genomics has recently created an evolving list of health-related genomic tests and family health history applications

3 Tier

1st Tier

1st Tier

Applications are recommended for clinical use by evidence-based panels and are supported by a systematic review of evidence establishing the validity and utility of these tests for their intended use.

• Newborn screening

• BRCA1 and BRCA2

• Colorectal cancer surveillance

• evidence-based recommendation from the Evaluation of Genomic Applications in Practice and Prevention (EGAPP)

http://www.egappreviews.org/recommendations/index.htm

2nd Tier

2nd Tier

Applications have evidence establishing validity and promising utility, but they lack evidence-based recommendations for their use, or evidence-based panels have simply found insufficient evidence.

• pharmacogenomic testing individualization of the choice or dose of a drug.

• Family history of Diabetes Mellitus

3rd Tier

Genomic and family health history applications have not demonstrated adequate analytic validity, clinical validity, or clinical utility.

Such applications are not ready for routine practice but may be considered in clinical and population research.

• whole genome sequencing/next-generation sequencing

Summary

"personalization“Prevention

Ẋ ready for "prime time.“Ẋ Lack of evidence

Web Resources

CDC. 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.

Michael Scott Bowen

Scott Bowen is the deputy director of the Office of Public Health Genomics. He earned his Masters of Public Health degree in Epidemiology from Tulane University. Mr. Bowen came to CDC under the Outstanding Scholar Program in 1992 and had previously served on active duty as a non-commissioned officer with the U.S. Army. His past CDC roles included service as the Management Officer for the CDC/OD offices and as the deputy director for the Division of Public Health Surveillance and Informatics. He has also worked for the Agency for Toxic Substances and Disease Registry where he served as an epidemiologist and as deputy chief of the Health Investigations Branch.

Thank you