Taking Research and Development to the Clinic: Issues for Physicians. AAAS/FDLI Colloquium I Diagnostics and Diagnoses Paths to Personalized Medicine Howard Levy, MD, PhD Johns Hopkins University June 1, 2009. What is Personalized Medicine?. Biomarkers and genetic tests
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AAAS/FDLI Colloquium I
Diagnostics and Diagnoses
Paths to Personalized Medicine
Howard Levy, MD, PhD
Johns Hopkins University
June 1, 2009
Can biomarkers improve both?
Order a test
Get it paid for
Get it done
(now & future)
Apply result in clinical careUsing a Biomarker
Does the biomarker improve clinical care?
What are the costs?
At the right time
In the right dose
↓ Adverse eventsPharmacogenetics
N Engl J Med
February 19, 2009
Belief that clinical outcomes are inexorably defined by genetic factors
“It’s tough to make predictions, especially about the future”
-Dan Quayle, Casey Stengel, et al.
“The future ain’t what it used to be”
(DNA & Non-DNA variants)
Positive tests ≠ Disease
Negative tests ≠ Health
Test Ordering & Payment
Receiving, Archiving and Accessing Results