Evidence map›Paper›PMID 27189072›Full record

ArticleDiagnostic pathology2016

Quantitative and qualitative characterization of Two PD-L1 clones: SP263 and E1L3N.

Jacquelyn Smith, Mark D Robida, Krista Acosta, Bharathi Vennapusa, Amita Mistry, Greg Martin, Alton Yates, H James Hnatyszyn

Abstract readComparative StudyEvaluation Study
In one paragraph

Article in Diagnostic pathology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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  4. Nature medicine · 2018
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  20. [Progress on the Study of PD-L1 Detection Methods in Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jacquelyn SmithCompanion Diagnostics Pharma Services, Assay Development, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
Mark D RobidaCompanion Diagnostics Pharma Services, Assay Development, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
Krista AcostaCompanion Diagnostics Pharma Services, Assay Development, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
Bharathi VennapusaCompanion Diagnostics Pharma Services, Pathology Office, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
Amita MistryCompanion Diagnostics Pharma Services, Pathology Office, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
Greg MartinCompanion Diagnostics, Project Management Office, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
Alton YatesCompanion Diagnostics, Pharma Services, Clinical Services Management, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
H James HnatyszynCompanion Diagnostics Pharma Services, CDx CAP/CLIA Lab Operations, Ventana Medical Systems Inc., Roche Tissue Diagnostics, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA. james.hnatyszyn@roche.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgrammed Death Ligand 1 (PD-L1) is an immune modulating protein expressed on the surface of various inflammatory cells, including T Cells, B Cells, dendritic cells, and macrophages. PD-L1 represents an important diagnostic target; expression of PD-L1 on the surface of tumor cells, or within tumor-associated immune cells, is an important predictor of likely response to targeted therapies. In this study, we describe the optimization of immunohistochemistry (IHC) assays using two PD-L1 antibodies (SP263 and E1L3N) and compare the performance of the optimized assays.

methodsFully automated immunohistochemical assays were optimized for the VENTANA PD-L1 (SP263) Rabbit Monoclonal Antibody and the PD-L1 (E1L3N®) XP® Rabbit mAb using instruments and detection chemistries from Ventana Medical Systems, Inc. ("SP263 assay" and "E1L3N assay," respectively). Tissue microarrays (TMAs) containing formalin fixed paraffin embedded (FFPE) non-small cell lung cancer (NSCLC) cases were used for the optimization and comparison staining. H scores were used for membrane scoring whereas percent positivity was used for tumor-associated immune cell scoring.

resultsOne-hundred NSCLC TMA case cores each stained with the SP263 and E1L3N assays were evaluated by two pathologists in a blinded study. Analysis of these specimens showed that the SP263 assay was more sensitive and had a wider dynamic range than the E1L3N assay. For sensitivity, many cases were found to be negative for membrane staining with the E1L3N assay, but had measurable staining with the SP263 assay. Dynamic range was demonstrated by the SP263 assay having well-distributed H scores while the E1L3N assay had a significantly higher proportion of cases clustered in the lowest H score bins. For tumor-associated immune cell staining, the two assays identified similar amounts of cells staining in each case, but the SP263 assay gave overall darker staining.

conclusionSince PD-L1 status is important for targeted therapies, having a specific and accurate diagnostic test is crucial for identifying patients who could benefit from these treatments. Due to its staining intensity, scoring range, and pathologist preference, the SP263 IHC assay has been deemed superior to the E1L3N IHC assay. Future clinical utility remains to be determined.

Indexed as

Antibodies, MonoclonalAnimalsB7-H1 AntigenBiomarkers, TumorCarcinoma, Non-Small-Cell LungHumansImmunohistochemistryLung NeoplasmsRabbitsStaining and LabelingTissue Array AnalysisAntibodies, MonoclonalB7-H1 AntigenBiomarkers, TumorCD274 protein, humanE1L3NIHCNSCLCPD-L1SP263

Identifiers

PMID27189072
PMCPMC4870735

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.