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An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1.

Publication ,  Journal Article
Cogswell, J; Inzunza, HD; Wu, Q; Feder, JN; Mintier, G; Novotny, J; Cardona, DM
Published in: Mol Diagn Ther
February 2017

AIM: Nivolumab, a fully human immunoglobulin G4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, has activity in melanoma, non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), and Hodgkin lymphoma. Nivolumab is approved in the USA and EU for advanced melanoma, NSCLC, and RCC, and relapsed Hodgkin lymphoma in the USA. Programmed death-ligand 1 (PD-L1), a PD-1 ligand, is expressed on mononuclear leukocytes, myeloid cells, and tumor cells. PD-L1 is being investigated as a potential biomarker to predict the association of tumor PD-L1 expression with nivolumab efficacy. METHODS: Bristol-Myers Squibb and Dako previously reported on an automated PD-L1 immunohistochemical (IHC) assay that detects cell surface PD-L1 in formalin-fixed, paraffin-embedded, human tumor tissue specimens using Dako's Autostainer Link 48. The primary antibody for this assay is a rabbit monoclonal antihuman PD-L1 antibody, clone 28-8. Another rabbit monoclonal antihuman PD-L1 antibody, clone E1L3N, was compared with 28-8 for specificity and sensitivity using an identical detection method followed by vendor-recommended detection methods. RESULTS: Using PD-L1 null clones of L2987 and ES-2 tumor cell lines, both antibodies were specific for detection of PD-L1 on the plasma membrane, although E1L3N also stained cytoplasm in ES-2 knockout cells. Using the identical method, E1L3N was slightly more sensitive than 28-8 based on staining intensities. Using manufacturer-recommended detection methods and predefined scoring criteria for plasma membrane staining of tumor and immune cells, 28-8 demonstrated significantly improved detection compared with E1L3N. CONCLUSIONS: Epitope retrieval and highly sensitive detection reagents are key determinants in IHC detection of PD-L1.

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Published In

Mol Diagn Ther

DOI

EISSN

1179-2000

Publication Date

February 2017

Volume

21

Issue

1

Start / End Page

85 / 93

Location

New Zealand

Related Subject Headings

  • Sensitivity and Specificity
  • Pharmacology & Pharmacy
  • Oncology & Carcinogenesis
  • Nivolumab
  • Melanoma
  • Immunohistochemistry
  • Humans
  • Genetic Markers
  • Epitopes
  • Cell Line, Tumor
 

Citation

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MLA
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Cogswell, J., Inzunza, H. D., Wu, Q., Feder, J. N., Mintier, G., Novotny, J., & Cardona, D. M. (2017). An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1. Mol Diagn Ther, 21(1), 85–93. https://doi.org/10.1007/s40291-016-0237-9
Cogswell, John, H David Inzunza, Qiuyan Wu, John N. Feder, Gabe Mintier, James Novotny, and Diana M. Cardona. “An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1.Mol Diagn Ther 21, no. 1 (February 2017): 85–93. https://doi.org/10.1007/s40291-016-0237-9.
Cogswell J, Inzunza HD, Wu Q, Feder JN, Mintier G, Novotny J, et al. An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1. Mol Diagn Ther. 2017 Feb;21(1):85–93.
Cogswell, John, et al. “An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1.Mol Diagn Ther, vol. 21, no. 1, Feb. 2017, pp. 85–93. Pubmed, doi:10.1007/s40291-016-0237-9.
Cogswell J, Inzunza HD, Wu Q, Feder JN, Mintier G, Novotny J, Cardona DM. An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1. Mol Diagn Ther. 2017 Feb;21(1):85–93.
Journal cover image

Published In

Mol Diagn Ther

DOI

EISSN

1179-2000

Publication Date

February 2017

Volume

21

Issue

1

Start / End Page

85 / 93

Location

New Zealand

Related Subject Headings

  • Sensitivity and Specificity
  • Pharmacology & Pharmacy
  • Oncology & Carcinogenesis
  • Nivolumab
  • Melanoma
  • Immunohistochemistry
  • Humans
  • Genetic Markers
  • Epitopes
  • Cell Line, Tumor