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Monitoring of tisagenlecleucel transgene DNA using a quantitative polymerase chain reaction assay

Molecular therapy. Methods & clinical development, 2021-03, Vol.20, p.535-541

2021

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74 Novel approach for profiling immune-tumor cell interactions and mutations in the same tumor section by multiplex immunohistochemistry and NGS in immuno-oncology trials

Journal for immunotherapy of cancer, 2020-11, Vol.8 (Suppl 3), p.A45-A45

2020

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CD80 (B7.1) is expressed on both malignant B cells and nonmalignant stromal cells in non‐Hodgkin lymphoma

Cytometry. Part B, Clinical cytometry, 2012-03, Vol.82B (2), p.112-119

2012

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Quantitative Spatial Profiling of PD-1/PD-L1 Interaction and HLA-DR/IDO-1 Predicts Improved Outcomes of Anti-PD-1 Therapies in Metastatic Melanoma

Clinical cancer research, 2018-11, Vol.24 (21), p.5250-5260

2018

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Abstract 2754: Exploring the interplay between TAM, PD-L1 and immunosuppressive molecules by a novel multiplex immunofluorescence assay in cancer immunotherapy trials

Cancer research (Chicago, Ill.), 2021-07, Vol.81 (13_Supplement), p.2754-2754

2021

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Peptide Binding and Presentation by Mouse CD1

Science (American Association for the Advancement of Science), 1995-07, Vol.269 (5221), p.223-226

1995

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Abstract P1-09-08: Development and characterization of PTEN IHC assay for testing breast cancer patients specimens

Cancer research (Chicago, Ill.), 2020-02, Vol.80 (4_Supplement), p.P1-P1-09-08

2020

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Abstract 3992: Modular ddPCR assay design for highly sensitive single nucleotide variant detection

Cancer research (Chicago, Ill.), 2022-06, Vol.82 (12_Supplement), p.3992-3992

2022

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Monitoring CAR‐T cell kinetics in clinical trials by multiparametric flow cytometry: Benefits and challenges

Cytometry. Part B, Clinical cytometry, 2021-01, Vol.100 (1), p.72-78

2021

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Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part III – analytical issues

Cytometry. Part B, Clinical cytometry, 2013-09, Vol.84 (5), p.291-308

2013

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Predictive evaluation of quantitative spatial profiling of the tumor microenvironment by multiplex immunofluorescence in recurrent glioblastoma treated with PD-1 inhibitors

Journal of clinical oncology, 2020-05, Vol.38 (15_suppl), p.e14524-e14524

2020

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Predictive value of circulating B cells and T cell subsets in melanoma patients treated with neoadjuvant ipilimumab and interferon

Journal of clinical oncology, 2020-05, Vol.38 (15_suppl), p.e15036-e15036

2020

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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Bioanalysis, 2019-12, Vol.11 (24), p.2207-2244

2019

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Best Practices for Validation of Measurable Residual Disease Assessments By Multiparameter Flow Cytometry in Emerging Clinical Trials of Acute Myeloid Leukemia

Blood, 2020-11, Vol.136 (Supplement 1), p.22-23

2020

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BIOM-27. PREDICTIVE EVALUATION OF QUANTITATIVE SPATIAL PROFILING OF THE TUMOR MICROENVIRONMENT BY MULTIPLEX IMMUNOFLUORESCENCE IN RECURRENT GLIOBLASTOMA TREATED WITH PD-1 INHIBITORS

Neuro-oncology (Charlottesville, Va.), 2020-11, Vol.22 (Supplement_2), p.ii7-ii7

2020

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Maternal anti-placental reactivity in natural, immunologically-mediated fetal resorptions

The Journal of immunology (1950), 1994-05, Vol.152 (10), p.4903-4911

1994

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Abstract 310: Immunophenotyping tumors by novel multiplex immunofluorescence and AQUA (Automated Quantitative Analyses) algorithms to guide development of immunotherapies

Cancer research (Chicago, Ill.), 2020-08, Vol.80 (16_Supplement), p.310-310

2020

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Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses

Cytometry. Part B, Clinical cytometry, 2021-01, Vol.100 (1), p.79-91

2021

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Abstract 1302: High complexity flow cytometry panels to monitor target expression, T-cell activation and suppresssion by novel immunotherapies in hematomalignancy clinical trials

Cancer research (Chicago, Ill.), 2015-08, Vol.75 (15_Supplement), p.1302-1302

2015

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Abstract 3388: Analytical validation and clinical verification of phosphoprotein biomarker modulation using a novel preservation system-based flow cytometry assay in multiple myeloma clinical trials

Cancer research (Chicago, Ill.), 2015-08, Vol.75 (15_Supplement), p.3388-3388

2015

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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness

Bioanalysis, 2022-06, Vol.14 (11), p.737-793

2022

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16 th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status

Bioanalysis, 2024-06, Vol.16 (11), p.505-517

2024

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Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia

Blood, 2010-01, Vol.115 (3), p.489-495

2010

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Abstract LB-96: A novel blood preservation system to study oncogenic signaling pathway biomarkers by flow cytometry in leukemia/lymphoma clinical trials

Cancer research (Chicago, Ill.), 2014-10, Vol.74 (19_Supplement), p.LB-96-LB-96

2014

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Abstract 3734: Development of a nanostring copy number assay for a customized 55 gene panel using challenging formalin-fixed paraffin-embedded (ffpe) tumor samples

Cancer research (Chicago, Ill.), 2014-10, Vol.74 (19_Supplement), p.3734-3734

2014

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Monitoring of tisagenlecleucel transgene DNA using a quantitative polymerase chain reaction assay

74 Novel approach for profiling immune-tumor cell interactions and mutations in the same tumor section by multiplex immunohistochemistry and NGS in immuno-oncology trials

CD80 (B7.1) is expressed on both malignant B cells and nonmalignant stromal cells in non‐Hodgkin lymphoma

Quantitative Spatial Profiling of PD-1/PD-L1 Interaction and HLA-DR/IDO-1 Predicts Improved Outcomes of Anti-PD-1 Therapies in Metastatic Melanoma

Abstract 2754: Exploring the interplay between TAM, PD-L1 and immunosuppressive molecules by a novel multiplex immunofluorescence assay in cancer immunotherapy trials

Peptide Binding and Presentation by Mouse CD1

Abstract P1-09-08: Development and characterization of PTEN IHC assay for testing breast cancer patients specimens

Abstract 3992: Modular ddPCR assay design for highly sensitive single nucleotide variant detection

Monitoring CAR‐T cell kinetics in clinical trials by multiparametric flow cytometry: Benefits and challenges

Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part III – analytical issues

Predictive evaluation of quantitative spatial profiling of the tumor microenvironment by multiplex immunofluorescence in recurrent glioblastoma treated with PD-1 inhibitors

Predictive value of circulating B cells and T cell subsets in melanoma patients treated with neoadjuvant ipilimumab and interferon

Best Practices for Validation of Measurable Residual Disease Assessments By Multiparameter Flow Cytometry in Emerging Clinical Trials of Acute Myeloid Leukemia

BIOM-27. PREDICTIVE EVALUATION OF QUANTITATIVE SPATIAL PROFILING OF THE TUMOR MICROENVIRONMENT BY MULTIPLEX IMMUNOFLUORESCENCE IN RECURRENT GLIOBLASTOMA TREATED WITH PD-1 INHIBITORS

Maternal anti-placental reactivity in natural, immunologically-mediated fetal resorptions

Abstract 310: Immunophenotyping tumors by novel multiplex immunofluorescence and AQUA (Automated Quantitative Analyses) algorithms to guide development of immunotherapies

Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses

Abstract 1302: High complexity flow cytometry panels to monitor target expression, T-cell activation and suppresssion by novel immunotherapies in hematomalignancy clinical trials

Abstract 3388: Analytical validation and clinical verification of phosphoprotein biomarker modulation using a novel preservation system-based flow cytometry assay in multiple myeloma clinical trials

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness

16 th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status

Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia

Abstract LB-96: A novel blood preservation system to study oncogenic signaling pathway biomarkers by flow cytometry in leukemia/lymphoma clinical trials

Abstract 3734: Development of a nanostring copy number assay for a customized 55 gene panel using challenging formalin-fixed paraffin-embedded (ffpe) tumor samples

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