2020
Digital quantitative assessment of PD-L1 using digital spatial profiling
Gupta S, Zugazagoitia J, Martinez-Morilla S, Fuhrman K, Rimm DL. Digital quantitative assessment of PD-L1 using digital spatial profiling. Laboratory Investigation 2020, 100: 1311-1317. PMID: 32249818, PMCID: PMC7502436, DOI: 10.1038/s41374-020-0424-5.Peer-Reviewed Original ResearchConceptsTissue microarrayPD-L1Digital spatial profilingDeath 1 ligand 1 expressionPD-L1 immunohistochemistry assaysDigital quantitative assessmentDigital Spatial ProfilerLigand 1 expressionPD-L1 assaysCompanion diagnostic testingCell linesImmune therapyPredictive markerImmune cellsImmunohistochemistry assaysQuantitative immunohistochemistryUS FoodDrug AdministrationDiagnostic testingImmunohistochemistryNCounter platformTumor cellsDifferent scoring methodsMultiple studiesDifferent antibodies
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, J. 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
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 settings
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