Featured Publications
Tissue Age Affects Antigenicity and Scoring for the 22C3 Immunohistochemistry Companion Diagnostic Test
Fernandez A, Gaule P, Rimm D. Tissue Age Affects Antigenicity and Scoring for the 22C3 Immunohistochemistry Companion Diagnostic Test. Modern Pathology 2023, 36: 100159. PMID: 36925070, PMCID: PMC10502188, DOI: 10.1016/j.modpat.2023.100159.Peer-Reviewed Original ResearchConceptsPD-L1 signalTumor proportion scoreTissue microarray cohortCell lung cancerPrevious clinical diagnosisWhole tissue sectionsCompanion diagnostic testsMultiple cancer typesMicroarray cohortTMA cohortLaboratory-developed testsPD-L1NSCLC casesLung cancerProportion scorePositive stainingAntibody 22C3Immunohistochemistry testsClinical diagnosisExtracellular domainCancer typesDiagnostic testsArchival tissueDomain antigenAntibodies
2023
Multi-Institutional Study of Pathologist Reading of the Programmed Cell Death Ligand-1 Combined Positive Score Immunohistochemistry Assay for Gastric or Gastroesophageal Junction Cancer
Fernandez A, Robbins C, Gaule P, Agostini-Vulaj D, Anders R, Bellizzi A, Chen W, Chen Z, Gopal P, Zhao L, Lisovsky M, Liu X, Shia J, Wang H, Yang Z, McCann L, Chan Y, Weidler J, Bates M, Zhang X, Rimm D. Multi-Institutional Study of Pathologist Reading of the Programmed Cell Death Ligand-1 Combined Positive Score Immunohistochemistry Assay for Gastric or Gastroesophageal Junction Cancer. Modern Pathology 2023, 36: 100128. PMID: 36889057, PMCID: PMC10198879, DOI: 10.1016/j.modpat.2023.100128.Peer-Reviewed Original ResearchConceptsOverall percent agreementCut pointsReal-world settingHigher cut pointsCell death ligand 1Percent agreementGastroesophageal junction cancerPD-L1 immunohistochemistryDeath ligand 1Companion diagnostic testsMessenger RNA measurementsJunction cancerCancer casesImmunohistochemistry assaysIHC resultsDrug AdministrationPredictive valueScoring systemRange of assaysDiagnostic testsInstitutional studyRNA measurementsImmunohistochemistryPoor specificityPathologist's readingMulti-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry
Robbins C, Fernandez A, Han G, Wong S, Harigopal M, Podoll M, Singh K, Ly A, Kuba M, Wen H, Sanders M, Brock J, Wei S, Fadare O, Hanley K, Jorns J, Snir O, Yoon E, Rabe K, Soong T, Reisenbichler E, Rimm D. Multi-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry. Modern Pathology 2023, 36: 100032. PMID: 36788069, PMCID: PMC10278086, DOI: 10.1016/j.modpat.2022.100032.Peer-Reviewed Original ResearchConceptsOverall percent agreementHuman epidermal growth factor 2HER2 IHCReal-world settingEpidermal growth factor 2HER2-negative statusBreast cancer biopsiesCompanion diagnostic testsMulti-institutional assessmentGrowth factor 2Breast cancerImmunohistochemistry assaysCancer biopsiesHER2 immunohistochemistryPathologist concordanceIHCClinical standardsPercent agreementDiagnostic testsSubstantial discordanceERBB2 geneInterrater reliabilityPathologistsFactor 2Concordance
2021
Putting the Microenvironment into the Immunotherapy Companion Diagnostic
Moutafi M, Rimm DL. Putting the Microenvironment into the Immunotherapy Companion Diagnostic. Clinical Cancer Research 2021, 27: 3812-3814. PMID: 33986024, DOI: 10.1158/1078-0432.ccr-21-1238.Peer-Reviewed Original Research
2019
Closed system RT-qPCR as a potential companion diagnostic test for immunotherapy outcome in metastatic melanoma
Gupta S, McCann L, Chan YGY, Lai EW, Wei W, Wong PF, Smithy JW, Weidler J, Rhees B, Bates M, Kluger HM, Rimm DL. Closed system RT-qPCR as a potential companion diagnostic test for immunotherapy outcome in metastatic melanoma. Journal For ImmunoTherapy Of Cancer 2019, 7: 254. PMID: 31533832, PMCID: PMC6751819, DOI: 10.1186/s40425-019-0731-9.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCD8 AntigensFemaleFollow-Up StudiesGene Expression ProfilingHumansInterferon Regulatory Factor-1MaleMelanomaMiddle AgedMonitoring, ImmunologicPrognosisProgrammed Cell Death 1 Ligand 2 ProteinProgression-Free SurvivalReal-Time Polymerase Chain ReactionRetrospective StudiesReverse Transcriptase Polymerase Chain ReactionRNA, MessengerSkin NeoplasmsConceptsCompanion diagnostic testsImmunotherapy outcomesMelanoma patientsClinical benefitAnti-PD-1 therapyImmune checkpoint inhibitor therapyMRNA expressionQuantitative immunofluorescenceDiagnostic testsCheckpoint inhibitor therapyReal-time quantitative reverse transcription polymerase chain reactionMetastatic melanoma patientsQuantitative reverse transcription polymerase chain reactionReverse transcription-polymerase chain reactionTranscription-polymerase chain reactionYale Pathology archivesParaffin-embedded tissue sectionsAdjuvant settingICI therapyOS associationInhibitor therapyBaseline variablesMetastatic melanomaPredictive biomarkersPolymerase chain reactionReanalysis of the NCCN PD-L1 companion diagnostic assay study for lung cancer in the context of PD-L1 expression findings in triple-negative breast cancer
Rimm DL, Han G, Taube JM, Yi ES, Bridge JA, Flieder DB, Homer R, Roden AC, Hirsch FR, Wistuba II, Pusztai L. Reanalysis of the NCCN PD-L1 companion diagnostic assay study for lung cancer in the context of PD-L1 expression findings in triple-negative breast cancer. Breast Cancer Research 2019, 21: 72. PMID: 31196152, PMCID: PMC6567382, DOI: 10.1186/s13058-019-1156-6.Peer-Reviewed Original ResearchConceptsPD-L1 expressionImmune cell PD-L1 expressionLung cancerImmune cellsTriple-negative breast cancerEasy scoring methodCompanion diagnostic testsPD-L1Immune therapyBreast cancerImmunohistochemical testsBetter outcomesLarger studyTumor cellsDiagnostic testsCancerExpression findingsCellsExpressionPoor agreementScoring methodTherapyTrials
2017
A Quantitative Comparison of Antibodies to Programmed Cell Death 1 Ligand 1
Gaule P, Smithy JW, Toki M, Rehman J, Patell-Socha F, Cougot D, Collin P, Morrill P, Neumeister V, Rimm DL. A Quantitative Comparison of Antibodies to Programmed Cell Death 1 Ligand 1. JAMA Oncology 2017, 3: 256-259. PMID: 27541827, PMCID: PMC5491359, DOI: 10.1001/jamaoncol.2016.3015.Peer-Reviewed Original ResearchPD-L1 expressionPD-L1Tissue microarrayImmunohistochemical analysisCell death 1 ligand 1PD-1 axis inhibitorsDeath 1 ligand 1Quantitative immunofluorescenceCell linesPredictive diagnostic testsTumor tissue coresPD-L1 proteinPrediction of responseYale Pathology archivesLung cancerClinical utilityPathology archivesDiagnostic testsMonoclonal antibodiesAntibodiesTissue controlsProtein levelsTissue coresLigand 1Concordant results
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
2012
Quantitative Assessment of Effect of Preanalytic Cold Ischemic Time on Protein Expression in Breast Cancer Tissues
Neumeister VM, Anagnostou V, Siddiqui S, England AM, Zarrella ER, Vassilakopoulou M, Parisi F, Kluger Y, Hicks DG, Rimm DL. Quantitative Assessment of Effect of Preanalytic Cold Ischemic Time on Protein Expression in Breast Cancer Tissues. Journal Of The National Cancer Institute 2012, 104: 1815-1824. PMID: 23090068, PMCID: PMC3514166, DOI: 10.1093/jnci/djs438.Peer-Reviewed Original ResearchMeSH KeywordsA Kinase Anchor ProteinsBiomarkers, TumorBiopsy, Large-Core NeedleBreast NeoplasmsCold IschemiaConfounding Factors, EpidemiologicFalse Negative ReactionsFemaleFixativesFluorescent Antibody TechniqueFormaldehydeGene Expression Regulation, NeoplasticHumansHypoxia-Inducible Factor 1, alpha SubunitKi-67 AntigenMastectomy, SegmentalMatched-Pair AnalysisMinor Histocompatibility AntigensProspective StudiesProto-Oncogene ProteinsReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneResearch DesignTime FactorsConceptsCold ischemic timeIschemic timeBreast cancer tissuesEstrogen receptorCancer tissuesLoss of antigenicityBreast cancer resectionProtein expressionCore needle biopsyCompanion diagnostic testsConditions of hypoxiaFalse-negative resultsBreast cancer biomarkersCancer resectionProgesterone receptorNeedle biopsyRecent guidelinesCold ischemiaBreast cancerTissue microarrayEvidence of lossQuantitative immunofluorescenceDiagnostic testsAntigenicityAQUA method
2011
Cancer and Leukemia Group B Pathology Committee Guidelines for Tissue Microarray Construction Representing Multicenter Prospective Clinical Trial Tissues
Rimm DL, Nielsen TO, Jewell SD, Rohrer DC, Broadwater G, Waldman F, Mitchell KA, Singh B, Tsongalis GJ, Frankel WL, Magliocco AM, Lara JF, Hsi ED, Bleiweiss IJ, Badve SS, Chen B, Ravdin PM, Schilsky RL, Thor A, Berry DA. Cancer and Leukemia Group B Pathology Committee Guidelines for Tissue Microarray Construction Representing Multicenter Prospective Clinical Trial Tissues. Journal Of Clinical Oncology 2011, 29: 2282-2290. PMID: 21519016, PMCID: PMC3107745, DOI: 10.1200/jco.2010.33.2023.Peer-Reviewed Original ResearchConceptsMulti-institutional clinical trialsPractice-changing evidenceProportion of patientsCooperative Oncology GroupCooperative group studiesCompanion diagnostic testsCollection of tissuesOncology GroupClinical trialsPathology CommitteeStudy populationCommittee guidelinesSuch trialsDiagnostic testsBiomarker studiesGroup studyPrecious tissuePatientsCancerTissueNumber of assaysTrialsFacility directorsGuidelines
2010
Pre-analytic variables and phospho-specific antibodies: the Achilles heel of immunohistochemistry
Siddiqui S, Rimm DL. Pre-analytic variables and phospho-specific antibodies: the Achilles heel of immunohistochemistry. Breast Cancer Research 2010, 12: 113. PMID: 21176180, PMCID: PMC3046444, DOI: 10.1186/bcr2782.Peer-Reviewed Original ResearchConceptsCold ischemic timePre-analytic variablesIschemic timeCore needle biopsyCompanion diagnostic testingCompanion diagnostic testsBreast cancer researchProgesterone receptorNeedle biopsyBreast cancerEstrogen receptorCritical therapyDiagnostic testingDiagnostic testsClassic markersImmunohistochemistryCancer researchPhospho-specific antibodiesReceptorsMarkersAchilles heel