2022
Quantitative measurement of HER2 expression to subclassify ERBB2 unamplified breast cancer.
Moutafi M, Robbins C, Yaghoobi V, Fernandez A, Martinez-Morilla S, Xirou V, Bai Y, Song Y, Gaule P, Krueger J, Bloom K, Hill S, Liebler D, Fulton R, Rimm D. Quantitative measurement of HER2 expression to subclassify ERBB2 unamplified breast cancer. Laboratory Investigation 2022, 102: 1101-1108. PMID: 36775350, DOI: 10.1038/s41374-022-00804-9.Peer-Reviewed Original ResearchConceptsHER2 expressionBreast cancerAttomol/HER2 proteinBreast cancer patientsBreast cancer casesOptimal patient careLevels of HER2Trastuzumab deruxtecanT-DXdCancer patientsLow HER2Cancer casesConventional assaysHER2Patient careAntibody concentrationsQuantitative immunofluorescenceAntibody drugsCancerCell linesAssaysExpressionHER2 detectionLower range
2019
Quantitative assessment of PD-L1 as an analyte in immunohistochemistry diagnostic assays using a standardized cell line tissue microarray
Martinez-Morilla S, McGuire J, Gaule P, Moore L, Acs B, Cougot D, Gown AM, Yaziji H, Wang WL, Cartun RW, Hornick JL, Sholl LM, Qiu J, Mino-Kenudson M, Yi ES, Beasley MB, Merrick DT, Ambaye AB, Zhang ZJ, Walker J, Rimm DL. Quantitative assessment of PD-L1 as an analyte in immunohistochemistry diagnostic assays using a standardized cell line tissue microarray. Laboratory Investigation 2019, 100: 4-15. PMID: 31409885, PMCID: PMC6920558, DOI: 10.1038/s41374-019-0295-9.Peer-Reviewed Original ResearchConceptsTissue microarrayPD-L1Quantitative immunofluorescencePD-L1 expressionPD-L1 immunohistochemistryMulti-institutional settingRoutine clinical samplesCell linesPredictive markerClinical trialsTumor typesIHC assaysQuantitative digital image analysisImmunohistochemistryCut pointsClinical samplesAntibodiesFDAInter-assay comparisonsDiagnostic assaysIsogenic cell linesAssaysDigital image analysisSubjective assessmentLow levels“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