2018
Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing
Kim AS, Bartley AN, Bridge JA, Kamel-Reid S, Lazar AJ, Lindeman NI, Long TA, Merker JD, Rai AJ, Rimm DL, Rothberg PG, Vasalos P, Moncur JT. Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing. JAMA Oncology 2018, 4: 838-841. PMID: 29242895, PMCID: PMC6145687, DOI: 10.1001/jamaoncol.2017.4021.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorDNA, NeoplasmErbB ReceptorsGenes, erbB-1Genes, rasHumansLaboratory Proficiency TestingNeoplasmsParaffin EmbeddingProto-Oncogene Proteins B-rafProto-Oncogene Proteins p21(ras)Tissue FixationUnited StatesUnited States Food and Drug AdministrationConceptsLaboratory-developed testsPT responseCompanion diagnosticsClinical laboratory testingKRAS testingOncology CommitteeMAIN OUTCOMEUS FoodDrug AdministrationPractice characteristicsDiagnostic testingTumor contentProficiency testingVariant-specific differencesEGFRBRAFClinical diagnostic testingMajority of laboratoriesKRASAssaysLaboratory testingPerformance of laboratoriesKit manufacturersResponseParticipants
2013
A Retrospective Population-Based Comparison of HER2 Immunohistochemistry and Fluorescence In Situ Hybridization in Breast Carcinomas: Impact of 2007 American Society of Clinical Oncology/ College of American Pathologists Criteria
Schalper KA, Kumar S, Hui P, Rimm DL, Gershkovich P. A Retrospective Population-Based Comparison of HER2 Immunohistochemistry and Fluorescence In Situ Hybridization in Breast Carcinomas: Impact of 2007 American Society of Clinical Oncology/ College of American Pathologists Criteria. Archives Of Pathology & Laboratory Medicine 2013, 138: 213-9. PMID: 24164555, DOI: 10.5858/arpa.2012-0617-oa.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsCarcinomaCohort StudiesConnecticutFemaleHospitals, UniversityHumansImmunohistochemistryIn Situ Hybridization, FluorescenceMammary Glands, HumanMiddle AgedNeoplasm GradingNeoplasm InvasivenessNeoplasm ProteinsPractice Guidelines as TopicReceptor, ErbB-2Retrospective StudiesSocieties, MedicalUnited StatesUnited States Food and Drug Administration