1. A Tiered Approach to
Integrating Genomic Tests
Into Your Practice

2. Definition
Tiered Approach: Types
Genomic Tests: DNA screening test
Practice: Giving a diagnosis and prescribing a
treatment for medical condition
Combine DNA screening with medical treatment
to test the probability of certain disease.

3. Initiation
Office of Public Health Genomics at the Centers
for Disease Control and Prevention (CDC)

4. A New Era
Medicine 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.

5. 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

6. 1st Tier

7. 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.

8. • Newborn screening
• BRCA1 and BRCA2
• Colorectal cancer surveillance

9. • evidence-based recommendation from the
Evaluation of Genomic Applications in Practice
and Prevention (EGAPP)
http://www.egappreviews.org/recommendations/index.htm

10. 2nd Tier

11. 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.

12. • pharmacogenomic testing individualization of
the choice or dose of a drug.
• Family history of Diabetes Mellitus

13. 3rd Tier
Genomic and family health history applications
have not demonstrated adequate analytic
validity, clinical validity, or clinical utility.

14. Such applications are not ready for routine
practice but may be considered in clinical and
population research.
• whole genome sequencing/next-generation
sequencing

15. Summary
"personalization“
Prevention
Ẋ ready for "prime time.“
Ẋ Lack of evidence

16. Web Resources
CDC. Public Health Genomics. Genetic Testing
CDC. 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. 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.

18. Thank you