2023
Correlation of HER2 Protein Level With mRNA Level Quantified by RNAscope in Breast Cancer
Li X, Lee J, Gao Y, Zhang J, Bates K, Rimm D, Zhang H, Smith G, Lawson D, Meisel J, Chang J, Huo L. Correlation of HER2 Protein Level With mRNA Level Quantified by RNAscope in Breast Cancer. Modern Pathology 2023, 37: 100408. PMID: 38135153, DOI: 10.1016/j.modpat.2023.100408.Peer-Reviewed Original ResearchHER2 protein levelsHER2-low breast cancerT-DXdBreast cancerRNA levelsProtein levelsHER2 expressionEarly-stage breast cancerIHC H-scoresTrastuzumab deruxtecanTissue microarray coresClinical trialsMetastatic biopsiesImmunohistochemical assaysH-scoreDrug AdministrationResponse rateUS FoodPatientsIHC assaysCancerRNAscopeRegression analysisCell linesImmunofluorescence scoresMulti-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 reading
2022
Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit.
Hayes D, Herbst R, Myles J, Topalian S, Yohe S, Aronson N, Bellizzi A, Basu Roy U, Bradshaw G, Edwards R, El-Gabry E, Elvin J, Gajewski T, McShane L, Oberley M, Philip R, Rimm D, Rosenbaum J, Rubin E, Schlager L, Sherwood S, Stewart M, Taube J, Thurin M, Vasalos P, Laser J. Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit. JCO Precision Oncology 2022, 6: e2200454. PMID: 36446042, PMCID: PMC10530621, DOI: 10.1200/po.22.00454.Peer-Reviewed Original ResearchConceptsICI therapyImmune checkpoint inhibition therapyDeath ligand 1 (PD-L1) expressionMultiple predictive biomarkersTumor biomarker testsCheckpoint inhibition therapyLigand 1 expressionDeath ligand 1Field of oncologyICI benefitPredictive factorsPredictive biomarkersInhibition therapyNeoantigen expressionBiomarker testsHealth insurance organizationsUS FoodDrug AdministrationAmerican PathologistsMedicaid ServicesTherapyBiomarker developmentNational InstituteLigand 1Clinical application
2021
Comparison of programmed death-ligand 1 protein expression between primary and metastatic lesions in patients with lung cancer
Moutafi MK, Tao W, Huang R, Haberberger J, Alexander B, Ramkissoon S, Ross JS, Syrigos K, Wei W, Pusztai L, Rimm DL, Vathiotis IA. Comparison of programmed death-ligand 1 protein expression between primary and metastatic lesions in patients with lung cancer. Journal For ImmunoTherapy Of Cancer 2021, 9: e002230. PMID: 33833050, PMCID: PMC8039214, DOI: 10.1136/jitc-2020-002230.Peer-Reviewed Original ResearchConceptsPD-L1 expressionMetastatic lesionsLung cancer casesLung cancerCancer casesAdvanced stage non-small cell lung cancerNon-small cell lung cancerNon-squamous histologyCell lung cancerFuture patient managementDefinite diagnostic testSquamous histologyFoundation MedicineLymph nodesRoutine careHistologic subtypeMetastatic sitesPrimary lesionRetrospective studyAdrenal glandPrimary tumorPleural fluidPatient managementTrial designDrug Administration
2020
Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer
Reisenbichler ES, Han G, Bellizzi A, Bossuyt V, Brock J, Cole K, Fadare O, Hameed O, Hanley K, Harrison BT, Kuba MG, Ly A, Miller D, Podoll M, Roden AC, Singh K, Sanders MA, Wei S, Wen H, Pelekanou V, Yaghoobi V, Ahmed F, Pusztai L, Rimm DL. Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer. Modern Pathology 2020, 33: 1746-1752. PMID: 32300181, PMCID: PMC8366569, DOI: 10.1038/s41379-020-0544-x.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerNegative breast cancerOverall percent agreementPD-L1Intraclass correlation coefficientBreast cancerAdvanced triple-negative breast cancerPD-L1 positive casesImmune cell stainingMultiple pathologistsPD-L1 scoringMulti-institutional evaluationLung cancer studiesAtezolizumab therapySP142 assaySP263 assaysPatient selectionSP263SP142US FoodDrug AdministrationPathologist's assessmentPositive casesReal-world settingPercent agreementDigital 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
2019
“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy
Torlakovic E, Lim HJ, Adam J, Barnes P, Bigras G, Chan AWH, Cheung CC, Chung JH, Couture C, Fiset PO, Fujimoto D, Han G, Hirsch FR, Ilie M, Ionescu D, Li C, Munari E, Okuda K, Ratcliffe MJ, Rimm DL, Ross C, Røge R, Scheel AH, Soo RA, Swanson PE, Tretiakova M, To KF, Vainer GW, Wang H, Xu Z, Zielinski D, Tsao MS. “Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy. Modern Pathology 2019, 33: 4-17. PMID: 31383961, PMCID: PMC6927905, DOI: 10.1038/s41379-019-0327-4.Peer-Reviewed Original ResearchConceptsPD-L1 assaysPD-L1Drug AdministrationDiagnostic accuracyDifferent PD-L1 assaysPD-L1 assessmentPD-L1 immunohistochemistryMain outcome measuresQUADAS-2 criteriaRandom-effects modelDiagnostic accuracy studiesOutcome measuresMEDLINE databaseSystematic reviewPubMed platformSystematic searchAdministrationSearch termsSTARD 2015Accuracy studiesPrimary objectiveAssaysData abstractionDifferent clonesFood
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 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
2005
Translational Crossroads for Biomarkers
Bast RC, Lilja H, Urban N, Rimm DL, Fritsche H, Gray J, Veltri R, Klee G, Allen A, Kim N, Gutman S, Rubin MA, Hruszkewycz A. Translational Crossroads for Biomarkers. Clinical Cancer Research 2005, 11: 6103-6108. PMID: 16144908, DOI: 10.1158/1078-0432.ccr-04-2213.Peer-Reviewed Original ResearchConceptsNational Cancer InstituteBiomarker developmentCancer InstituteClinical needAccurate pretreatment stagingUseful laboratory testPrediction of responsePretreatment stagingCancer careDisease progressionOvarian cancerProstate cancerBreast cancerGroups of investigatorsEarly cancer detectionDrug AdministrationTumor typesPromising markerTissue specimensClinical paradigmSpecific markersBiomarkersCancerMultiple biomarkersNew markers