2023
Assessment of the Impact of Alternative Fixatives on HER2 Detection in Breast Cancer and Gastric Cancer Tumor Specimens
Feng W, Inoue R, Kuwata T, Niikura N, Fujii S, Kumaki N, Honda K, Xu L, Goetz A, Gaule P, Cogswell J, Rimm D, McGee R. Assessment of the Impact of Alternative Fixatives on HER2 Detection in Breast Cancer and Gastric Cancer Tumor Specimens. Applied Immunohistochemistry & Molecular Morphology 2023, 31: 339-345. PMID: 37093713, PMCID: PMC10155692, DOI: 10.1097/pai.0000000000001126.Peer-Reviewed Original ResearchConceptsNeutral buffered formalinNegative percentage agreementPositive percentage agreementOverall percentage agreementBreast cancerPercentage agreementHER2 statusHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusTumor samplesCell linesGastric cancer tumorsGastric cancer cell linesTumor tissue samplesClinical trial sitesCancer cell linesHER2 testingTumor specimensReal-world settingTumor tissueCancer tumorsBuffered formalinSitu hybridization assaysType of fixativeCentral laboratory
2020
Antibody validation for protein expression on tissue slides: a protocol for immunohistochemistry
MacNeil T, Vathiotis IA, Martinez-Morilla S, Yaghoobi V, Zugazagoitia J, Liu Y, Rimm DL. Antibody validation for protein expression on tissue slides: a protocol for immunohistochemistry. BioTechniques 2020, 69: 460-468. PMID: 32852223, PMCID: PMC7807291, DOI: 10.2144/btn-2020-0095.Peer-Reviewed Original ResearchMeSH KeywordsAntibodiesHumansImmunohistochemistryReproducibility of ResultsSubcellular FractionsTissue Fixation
2018
Macrodissection prior to closed system RT-qPCR is not necessary for estrogen receptor and HER2 concordance with IHC/FISH in breast cancer
Gupta S, Mani NR, Carvajal-Hausdorf DE, Bossuyt V, Ho K, Weidler J, Wong W, Rhees B, Bates M, Rimm DL. Macrodissection prior to closed system RT-qPCR is not necessary for estrogen receptor and HER2 concordance with IHC/FISH in breast cancer. Laboratory Investigation 2018, 98: 1076-1083. PMID: 29858579, PMCID: PMC6119113, DOI: 10.1038/s41374-018-0064-1.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, Intraductal, NoninfiltratingFemaleGene Expression Regulation, NeoplasticHumansImmunohistochemistryIn Situ Hybridization, FluorescenceParaffin EmbeddingPathology, ClinicalReal-Time Polymerase Chain ReactionReceptor, ErbB-2Receptors, EstrogenReproducibility of ResultsSensitivity and SpecificityTissue FixationConceptsIHC/FISHDCIS cohortRT-qPCRMRNA transcript levelsDuctal carcinoma casesFine needle aspiratesMRNA expression levelsHER2 concordanceER positivityDuctal carcinomaHER2 expressionGeneXpert systemCarcinoma casesInvasive tumorsNeedle biopsyBreast cancerEstrogen receptorClinical ImmunohistochemistryBiopsy areaTumor tissueMRNA expressionTumor areaCohortMRNA levelsMRNA markersComparison 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 ResearchConceptsLaboratory-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
2017
Proof of the quantitative potential of immunofluorescence by mass spectrometry
Toki MI, Cecchi F, Hembrough T, Syrigos KN, Rimm DL. Proof of the quantitative potential of immunofluorescence by mass spectrometry. Laboratory Investigation 2017, 97: 329-334. PMID: 28092364, PMCID: PMC5334147, DOI: 10.1038/labinvest.2016.148.Peer-Reviewed Original Research
2014
Preanalytical variables and phosphoepitope expression in FFPE tissue: quantitative epitope assessment after variable cold ischemic time
Vassilakopoulou M, Parisi F, Siddiqui S, England AM, Zarella ER, Anagnostou V, Kluger Y, Hicks DG, Rimm DL, Neumeister VM. Preanalytical variables and phosphoepitope expression in FFPE tissue: quantitative epitope assessment after variable cold ischemic time. Laboratory Investigation 2014, 95: 334-341. PMID: 25418580, DOI: 10.1038/labinvest.2014.139.Peer-Reviewed Original ResearchConceptsCold ischemic timeIschemic timeFormalin fixationCompanion diagnostic testingCancer patientsBreast cancerTissue microarrayPhospho-HSP27Breast tumorsDiagnostic testingQuantitative immunofluorescenceAQUA technologyPreanalytical variablesGene expression profilingLoss of antigenicityTissue samplesReproducible assessmentProtein levelsConfidence intervalsSpecimen collectionExpression levelsPhosphorylation levelsAntigenicityRoutine usageResearch settingsA tissue quality index: an intrinsic control for measurement of effects of preanalytical variables on FFPE tissue
Neumeister VM, Parisi F, England AM, Siddiqui S, Anagnostou V, Zarrella E, Vassilakopolou M, Bai Y, Saylor S, Sapino A, Kluger Y, Hicks DG, Bussolati G, Kwei S, Rimm DL. A tissue quality index: an intrinsic control for measurement of effects of preanalytical variables on FFPE tissue. Laboratory Investigation 2014, 94: 467-474. PMID: 24535259, PMCID: PMC4030875, DOI: 10.1038/labinvest.2014.7.Peer-Reviewed Original ResearchConceptsCold ischemic timeIschemic timeQuantitative immunofluorescenceLevel of expressionTissue qualityER expression levelsBreast cancer casesExpression levelsFormalin fixationInformative epitopesValidation cohortCancer casesBreast cohortProtein statusGlobal assessmentPatient samplesTissue cohortPreanalytical variablesEpitope expressionCohortIntrinsic controlMeasurement of effectsQuality IndexFFPE tissuesEpitopes
2012
Delay to formalin fixation ‘cold ischemia time': effect on ERBB2 detection by in-situ hybridization and immunohistochemistry
Portier BP, Wang Z, Downs-Kelly E, Rowe JJ, Patil D, Lanigan C, Budd GT, Hicks DG, Rimm DL, Tubbs RR. Delay to formalin fixation ‘cold ischemia time': effect on ERBB2 detection by in-situ hybridization and immunohistochemistry. Modern Pathology 2012, 26: 1-9. PMID: 22899285, DOI: 10.1038/modpathol.2012.123.Peer-Reviewed Original Research
2006
Classification of Breast Cancer Using Genetic Algorithms and Tissue Microarrays
Dolled-Filhart M, Rydén L, Cregger M, Jirström K, Harigopal M, Camp RL, Rimm DL. Classification of Breast Cancer Using Genetic Algorithms and Tissue Microarrays. Clinical Cancer Research 2006, 12: 6459-6468. PMID: 17085660, DOI: 10.1158/1078-0432.ccr-06-1383.Peer-Reviewed Original ResearchConceptsBreast cancerPatient outcomesTissue microarraySubset of patientsBreast cancer patientsTissue microarray platformInternal validation setRoutine pathology laboratoriesCancer patientsEstrogen receptorTissue biomarkersIndependent cohortTumor subtypesPredictive valueAcid-base analysisPathology laboratoryRNA expression studiesCancerTissue sectionsPatientsCohortOutcomesFurther validationObjective quantitative analysisBiomarker discovery