Gene protein detection platform—a comparison of a new human epidermal growth factor receptor 2 assay with conventional immunohistochemistry and fluorescence in situ hybridization platforms

Stålhammar, Gustav; Farrajota, Pedro; Olsson, Anna; Silva, Cristina; Hartman, Johan; Elmberger, Göran

doi:10.1016/j.anndiagpath.2015.04.002

Cited by 3 publications

(4 citation statements)

References 40 publications

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“…A similar tricolor HER2 GPA protocol and its performance were published by Varga et al in 2014. 63 The performance of our tricolor HER2 GPA assay has been evaluated further on breast cancer, [64][65][66][67] gastric cancer, 64,68,69 and lung cancer. 70 A publication by Li et al, 65 focused on HER2 equivocal cases, reported that HER2 GPA divided breast cancer cases accurately into HER2 positive, equivocal, and negative statuses and it aided in identification of HER2 heterogeneity well.…”

Section: Development Of Her2 Gene-protein Assaymentioning

confidence: 99%

“…Stålhammar et al identified another advantage with a single slide HER2 GPA approach as an IHC-guided ISH assay for selecting appropriate areas. 67 A pathologist can determine an area for HER2 DISH scoring based on HER2 IHC staining at a lower magnification. All publications concluded that HER2 GPA is an ideal test for HER2 equivocal cases that require additional HER2 testing.…”

Section: Development Of Her2 Gene-protein Assaymentioning

confidence: 99%

“…Thus, the use of HER2 GPA approach can optimize laboratory workflow and deliver faster, more accurate HER2 status assessment for patient management. Stålhammar et al identified another advantage with a single slide HER2 GPA approach as an IHC‐guided ISH assay for selecting appropriate areas . A pathologist can determine an area for HER2 DISH scoring based on HER2 IHC staining at a lower magnification.…”

Section: Introductionmentioning

confidence: 99%

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The assessment of HER2 status in breast cancer: the past, the present, and the future

Nitta

Kelly

Allred

et al. 2016

Pathology International

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Humanized monoclonal anti-human growth factor receptor 2 (HER2) antibody trastuzumab was approved for HER2 positive breast cancer patient treatment 11 years after the demonstration of HER2 gene amplification associated with the HER2 protein overexpression in breast cancer in 1987. HER2 positive status of breast cancer patients is assessed by HER2 gene amplification with in situ hybridization (ISH) and/or HER2 protein overexpression with immunohistochemistry (IHC). Because the discordance between quantitative HER2 ISH and subjective, semiquantitative HER2 IHC assay results is a well-recognized issue of HER2 testing, we developed an assay combining HER2 ISH and HER2 IHC assays (HER2 gene-protein assay; HER2 GPA) as one test on the same tissue section. HER2 GPA allows pathologists to score the HER2 gene and HER2 protein status simultaneously at the individual cell level. The possibility that HER2 GPA may become the next generation of HER2 testing is discussed, particularly for cases in which it is difficult to assess the HER2 status of breast cancer patients due to the HER2 heterogeneity.

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Section: Development Of Her2 Gene-protein Assaymentioning

confidence: 99%

Section: Development Of Her2 Gene-protein Assaymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The assessment of HER2 status in breast cancer: the past, the present, and the future

Nitta

Kelly

Allred

et al. 2016

Pathology International

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“…Similarly to our study, Li et al (33) exclusively used HER2 IHC equivocal (2+) samples (n = 50) for comparison between GPA and FISH and obtained a lower agreement (82%) than our study. Stålhammar et al (34) included HER2 IHC 2+ and 3+ samples and one equivocal ISH sample (n = 52) obtaining the same agreement (92.3%) as ours, using same guidelines (13). Unlike our study, they used whole tissue sections, which may cause more intra‐sample inter‐method variation in HER2/CEP17 counts, as heterogeneity and counting on different cell nuclei may be more pronounced compared to TMAs.…”

Section: Discussionmentioning

confidence: 71%

Evaluation of analytical accuracy of HER2 status in patients with breast cancer

Jensen

Thomas

Christensen

et al. 2020

APMIS

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Human epidermal growth factor receptor 2 (HER2) gene status and overexpression, occurring in~13.6% of primary breast cancers, is essential for identifying patients likely to benefit from biological treatment. In this method of evaluation study, we tested and compared the HER2 gene-protein assay (GPA) with routine HER2 immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). The GPA was evaluated using 67 formalin-fixed paraffin-embedded (FFPE) HER2 equivoval IHC (2+) breast cancer tissue samples. Overall, agreement between GPA silver in situ hybridization (SISH) and FISH was 91.9% (57/62). Regression analysis revealed slightly higher, but non-significant difference in HER2/chromosome enumeration probe 17 (CEP17) ratio for GPA as compared to FISH (p = 0.074). Intraclass correlation coefficients (ICCs) of 0.94 and Spearman´s rank correlation coefficients of 0.93 (p < 0.0001) for FISH and GPA SISH suggested strong inter-observer association for methods with one observer counting on average 0.23 significant higher for GPA SISH (p = 0.014). Intra-observer IHC method reproducibility was 52.6% (j = 0.3122, p = 0.004) and 79.7% (j = 0.6428, p = 0.9197), suggesting fair significant and substantial non-significant difference between tests for reviewers. Inter-observer reproducibility for IHC methods was 53%. While inter-observer reproducibility for experienced IHC interpretation suggested significant differences (j = 0.3636, p = 0.0332), unexperienced interpretation of IHC GPA suggested fair non-significant difference between reviewers (j = 0.3101, p = 0.0747). Using FISH as reference, the diagnostic indices for GPA SISH were as follows: sensitivity 100%, specificity 95% and accuracy 92%. Inaccuracy between tests was in 80% of cases due to ISH categorization as equivocal by one of the methods. IHC results highlight that it may be beneficial with a method for simultaneously visualization of HER2 gene and protein status.

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Study on Her2 Status and Relationship With Prognostic Factors in Invasive Breast Carcinoma

Cong

Trong

2018

JMP

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Background: To select patients with targeted breast cancer need to accurately determine the status of HER2 gene amplification. Therefore, HER2 gene amplification should be determined by in situ hybridization (ISH) for all of cases which HER2 positive (2+) by Immunohistochemistry (IHC) staining. Our study aims to apply IHC and DISH to detect HER2 status and relationship with prognostic factors in breast cancer. Subjects and research methods: Cross-sectional descriptive study; 92 patients were diagnosed with invasive breast carcinoma at Hue University Hospital and Hue Central Hospital. IHC and DISH are performed on the Benchmark machines (Ventana) of Roche Diagnostics. Molecular subtypes based on the classification of Saint Gallen (2011). Results: Tumor is usually located in the right breast (53.3%); tumor size > 2-5cm (46.7%); Invasive carcinoma not otherwise specified (73.9%); lymph node metastasis 59.8%, histologic grade 2 (60.3%); disease stage II (51.1%). ER (+) 42.4%, PR (+) 41.3%, HER2 (+) 34.8%, Ki67 (+) 59.8% of cases. The most common molecular subtype of breast cancer is Luminal B (28.3%). HER2 gene amplified by DISH in HER2 (2+) 46.2%, HER2 (3+) by 100%. HER2 gene amplification is associated with HER2 protein expression, molecular subtypes; There is no relationship with the disease stage. Conclusion: In addition to immunohistochemistry, gene amplification with DISH is useful for determining the status of the HER2 gene and supporting the accurate grouping molecular subtypes of breast cancer and target therapy. 34.8% HER2 positive by IHC staining; HER2 gene amplified by DISH in 46.2% of HER2 (2+) cases. There are relationship between the HER2 gene amplified and HER2 protein expression, molecular subtypes in invasive breast carcinoma. Key words: invasive breast cancer, immunohistochemistry, histologic grade, disease stage, molecular subtypes, Dual In Situ Hybridization, DISH

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Gene protein detection platform—a comparison of a new human epidermal growth factor receptor 2 assay with conventional immunohistochemistry and fluorescence in situ hybridization platforms

Cited by 3 publications

References 40 publications

The assessment of HER2 status in breast cancer: the past, the present, and the future

The assessment of HER2 status in breast cancer: the past, the present, and the future

Evaluation of analytical accuracy of HER2 status in patients with breast cancer

Study on Her2 Status and Relationship With Prognostic Factors in Invasive Breast Carcinoma

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