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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