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OCR for page 71
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary
Acronyms
ACCE Analytic validity; Clinical validity; Clinical utility; and Ethical, legal, and social implications
AHRQ Agency for Healthcare Research and Quality
AML acute myelogenous leukemia
ASCO American Society of Clinical Oncology
CALGB Cancer and Leukemia Group B
CAP College of American Pathologists
CDC Centers for Disease Control and Prevention
CDRH Center for Devices and Radiological Health
CF cystic fibrosis
CHOP cyclophosphamide, doxorubicin, vincristine, prednisone therapy
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare & Medicaid Services
CPT current procedural terminology
EGAPP Evaluation of Genomic Applications in Practice and Prevention
EGFR epidermal growth factor receptor
EMEA European Medicines Agency
ER estrogen receptor
OCR for page 72
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary
FDA Food and Drug Administration
FISH fluorescent in situ hybridization
FLT3 FMS-like tyrosine kinase 3
GAPPNet Genomic Applications in Practice and Prevention Network
HER2 human epidermal growth factor receptor 2
HHS U.S. Department of Health and Human Services
HRSA Health Resources and Services Administration
IOM Institute of Medicine
IVDMIA In Vitro Diagnostic Multivariate Index Assay
KRAS v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog
MEDCAC Medicare Evidence Development and Coverage Advisory Committee
NCI National Cancer Institute
NIH National Institutes of Health
NLA national limitation amount
OIVD Office of In Vitro Diagnostic Devices
PCR polymerase chain reaction
PET positron emission tomography
PFS progression-free survival
PMA premarket application
PSA prostate-specific antigen
SACGHS Secretary’s Advisory Committee on Genetics, Health, and Society
SACGT Secretary’s Advisory Committee on Genetic Testing
UGT1A1 UDP glucuronosyltransferase 1 family, polypeptide A1
USPSTF U.S. Preventive Services Task Force