Table 1.

List of acronyms.

Acronym	Term
CDx	Companion diagnostics
CER	Comparative effectiveness research
CLIA	Clinical Laboratories Improvement Amendments
CMS	Center for Medicare and Medicaid Services
DTC	Direct to consumer
EHR	Electronic health records
EU	European Union
FDA	Food and Drug Administration
FTC	Federal Trade Commission
GINA	Genetic Information Non-Discrimination Act
HIPAA	Health Insurance Portability and Accountability Act
HTA	Health technology assessment
ICH	International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IND	Investigational New Drug Application
IRB	Institutional review board
LDT	Laboratory developed test
NIH	National Institutes of Health
ODA	Orphan Drug Act
PHI	Protected health information
PM	Personalized medicine
PMA	Premarket approval
PMI	Personalized Medicine Initiative
PMR	Postmarket research studies
R&D	Research and development
RCT	Randomized controlled trial
SAE	Serious adverse events
SSRD	Single subject research design
USA	United States of America