Evidence map›Paper›PMID 25844540›Full record

ArticlePloS one2015

Fully automated fluorescent in situ hybridization (FISH) staining and digital analysis of HER2 in breast cancer: a validation study.

Elise M J van der Logt, Deborah A J Kuperus, Jan W van Setten, Marius C van den Heuvel, James E Boers, Ed Schuuring, Robby E Kibbelaar

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 16% of its field
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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Image analysis for bright-field HER2 in situ hybridization: validation for clinical use.Virchows Archiv : an international journal of pathology · 2025
    Article
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  8. Singular Nuclei Segmentation for AutomaticSensors (Basel, Switzerland) · 2022
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  9. Computer-aided scoring ofJournal of pathology informatics · 2022
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  10. Development of a high-sensitivity and short-duration fluorescenceFrontiers in cellular and infection microbiology · 2022
    Article
  11. Automatic quantification ofJournal of medical imaging (Bellingham, Wash.) · 2019
    Article
  12. Article
  13. Article
  14. Article
  15. Article
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

7 authors at 4 institutions in 1 country.

Elise M J van der LogtDepartment of Pathology, Pathology Friesland, Leeuwarden, The Netherlands; Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Deborah A J KuperusDepartment of Pathology, Pathology Friesland, Leeuwarden, The Netherlands.
Jan W van SettenDepartment of Pathology, Pathology Friesland, Leeuwarden, The Netherlands.
Marius C van den HeuvelDepartment of Pathology, Pathology Friesland, Leeuwarden, The Netherlands.
James E BoersDepartment of Pathology, Isala Klinieken, Zwolle, The Netherlands.
Ed SchuuringDepartment of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Robby E KibbelaarDepartment of Pathology, Pathology Friesland, Leeuwarden, The Netherlands.
Friesland College · NLIsala · NLUniversity Medical Center Groningen · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

HER2 assessment is routinely used to select patients with invasive breast cancer that might benefit from HER2-targeted therapy. The aim of this study was to validate a fully automated in situ hybridization (ISH) procedure that combines the automated Leica HER2 fluorescent ISH system for Bond with supervised automated analysis with the Visia imaging D-Sight digital imaging platform. HER2 assessment was performed on 328 formalin-fixed/paraffin-embedded invasive breast cancer tumors on tissue microarrays (TMA) and 100 (50 selected IHC 2+ and 50 random IHC scores) full-sized slides of resections/biopsies obtained for diagnostic purposes previously. For digital analysis slides were pre-screened at 20x and 100x magnification for all fluorescent signals and supervised-automated scoring was performed on at least two pictures (in total at least 20 nuclei were counted) with the D-Sight HER2 FISH analysis module by two observers independently. Results were compared to data obtained previously with the manual Abbott FISH test. The overall agreement with Abbott FISH data among TMA samples and 50 selected IHC 2+ cases was 98.8% (κ = 0.94) and 93.8% (κ = 0.88), respectively. The results of 50 additionally tested unselected IHC cases were concordant with previously obtained IHC and/or FISH data. The combination of the Leica FISH system with the D-Sight digital imaging platform is a feasible method for HER2 assessment in routine clinical practice for patients with invasive breast cancer.

Indexed as

Automation, LaboratoryBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleHumansImage Processing, Computer-AssistedIn Situ Hybridization, FluorescenceParaffin EmbeddingReproducibility of ResultsTissue Array AnalysisERBB2 protein, humanErb-b2 Receptor Tyrosine Kinases

Identifiers

PMID25844540
PMCPMC4386817
OpenAlexW2111282668

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.