2021
Determination of the number of observers needed to evaluate a subjective test and its application in two PD‐L1 studies
Han G, Schell MJ, Reisenbichler ES, Guo B, Rimm DL. Determination of the number of observers needed to evaluate a subjective test and its application in two PD‐L1 studies. Statistics In Medicine 2021, 41: 1361-1375. PMID: 34897773, PMCID: PMC10243718, DOI: 10.1002/sim.9282.Peer-Reviewed Original Research
2018
Ki67 reproducibility using digital image analysis: an inter-platform and inter-operator study
Acs B, Pelekanou V, Bai Y, Martinez-Morilla S, Toki M, Leung SCY, Nielsen TO, Rimm DL. Ki67 reproducibility using digital image analysis: an inter-platform and inter-operator study. Laboratory Investigation 2018, 99: 107-117. PMID: 30181553, DOI: 10.1038/s41374-018-0123-7.Peer-Reviewed Original Research
2016
Quantitative Assessment of the Heterogeneity of PD-L1 Expression in Non–Small-Cell Lung Cancer
McLaughlin J, Han G, Schalper KA, Carvajal-Hausdorf D, Pelakanou V, Rehman J, Velcheti V, Herbst R, LoRusso P, Rimm DL. Quantitative Assessment of the Heterogeneity of PD-L1 Expression in Non–Small-Cell Lung Cancer. JAMA Oncology 2016, 2: 1-9. PMID: 26562159, PMCID: PMC4941982, DOI: 10.1001/jamaoncol.2015.3638.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, MonoclonalAntibody SpecificityB7-H1 AntigenBiomarkers, TumorCarcinoma, Non-Small-Cell LungFemaleFluorescent Antibody TechniqueHumansImmunohistochemistryLung NeoplasmsMaleObserver VariationPredictive Value of TestsReproducibility of ResultsRetrospective StudiesTissue Array AnalysisConceptsTumor-infiltrating lymphocytesPD-L1 expressionPD-L1 antibodiesPD-L1 protein expressionCell lung cancerPD-L1Whole tissue sectionsQuantitative immunofluorescenceLung cancerChromogenic immunohistochemistryPoor concordanceDifferent PD-L1 antibodiesHigh tumor-infiltrating lymphocytesTumor PD-L1 expressionPD-L1 protein levelsCell lung cancer biopsiesMonoclonal antibodiesCurrent consensus guidelinesProtein expressionDurable clinical responsesMain outcome measuresEarly phase trialsLung cancer biopsiesRabbit monoclonal antibodyCorresponding tissue microarrays
2015
Expertise vs Evidence in Assessment of Breast Biopsies: An Atypical Science
Davidson NE, Rimm DL. Expertise vs Evidence in Assessment of Breast Biopsies: An Atypical Science. JAMA 2015, 313: 1109-1110. PMID: 25781438, DOI: 10.1001/jama.2015.1945.Peer-Reviewed Original Research
2014
Automated Objective Determination of Percentage of Malignant Nuclei for Mutation Testing
Viray H, Coulter M, Li K, Lane K, Madan A, Mitchell K, Schalper K, Hoyt C, Rimm DL. Automated Objective Determination of Percentage of Malignant Nuclei for Mutation Testing. Applied Immunohistochemistry & Molecular Morphology 2014, 22: 363-371. PMID: 24162261, PMCID: PMC3999345, DOI: 10.1097/pai.0b013e318299a1f6.Peer-Reviewed Original ResearchConceptsCriterion standardMalignant cellsMalignant nucleiCompanion diagnostic testsTumor cell percentageMutation testingEosin-stained tissuesCell percentageInForm softwareHistologic specimensTumor tissueColon adenocarcinomaTumor cellsDiagnostic testsPotential future toolDNA mutation testingTissue sectionsContinuous variablesFurther validationPathologist estimationAnalytic sensitivityVariant resultsDNA mutationsBenign nucleiTissue
2013
A Prospective, Multi-Institutional Diagnostic Trial to Determine Pathologist Accuracy in Estimation of Percentage of Malignant Cells
Viray H, Li K, Long TA, Vasalos P, Bridge JA, Jennings LJ, Halling KC, Hameed M, Rimm DL. A Prospective, Multi-Institutional Diagnostic Trial to Determine Pathologist Accuracy in Estimation of Percentage of Malignant Cells. Archives Of Pathology & Laboratory Medicine 2013, 137: 1545-9. PMID: 24168492, DOI: 10.5858/arpa.2012-0561-cp.Peer-Reviewed Original ResearchConceptsFalse-negative test resultsMalignant cellsMulti-institutional studyColon tissue specimensCriterion standardPatient careTissue specimensTumor tissueDiagnostic trialPathologists' accuracyGenetic alterationsNuclear countsPathologist estimationEstimation of percentageVisual estimationCurrent studyCellsTesting failures
2007
Quantitative analysis of estrogen receptor heterogeneity in breast cancer
Chung GG, Zerkowski MP, Ghosh S, Camp RL, Rimm DL. Quantitative analysis of estrogen receptor heterogeneity in breast cancer. Laboratory Investigation 2007, 87: 662-669. PMID: 17334408, DOI: 10.1038/labinvest.3700543.Peer-Reviewed Original ResearchAdenocarcinomaAutomationBiomarkers, TumorBreast NeoplasmsFemaleHumansImage Processing, Computer-AssistedImmunohistochemistryLinear ModelsNeoplasm ProteinsObserver VariationParaffin EmbeddingPrognosisProtein Array AnalysisReceptors, EstrogenReproducibility of ResultsResearch DesignRetrospective StudiesSensitivity and Specificity