Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma

Elena Lucas; Seema B Jabbar; Kyle Molberg; Yisheng Fang; Xian-Jin Xie; Sara Blacketer; Sunati Sahoo

doi:10.1097/PAI.0000000000000646

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Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma

Journal article

Peer reviewed

Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma

Elena Lucas, Seema B Jabbar, Kyle Molberg, Yisheng Fang, Xian-Jin Xie, Sara Blacketer and Sunati Sahoo

Applied immunohistochemistry & molecular morphology, Vol.27(6), pp.403-409

07/2019

DOI: 10.1097/PAI.0000000000000646

PMID: 31233398

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Abstract

We compared the performance of two Food and Drug Administration-approved HER2 immunohistochemistry (IHC) tests: HercepTest (Dako) and PATHWAY anti-HER2 (4B5) (Ventana). In total, 180 invasive breast carcinomas previously tested by both HercepTest and fluorescent in situ hybridization (FISH) were retested with 4B5. Three pathologists scored the HER2 IHC using the 2013 American Society of Clinical Oncology/College of American Pathologists guidelines. The HER2 IHC results were correlated with FISH. Among 135 equivocal cases by HercepTest, 100 (74.1%) were negative by 4B5. Among 45 positive HercepTest cases 9 (20%) were equivocal by 4B5. Among 135 equivocal HercepTest results, 100 (74.1%) were nonamplified, 18 (13.3%) equivocal, and 17 (12.6%) amplified by FISH. Among the 45 positive results with HercepTest, 2 (4.5%) were nonamplified and 1 (2.2%) was equivocal by FISH. All 37 positive and 3 negative by 4B5 cases were amplified by FISH. The absolute interobserver agreement was high for both tests (Fleiss kappa=0.838 for HercepTest and 0.771 for 4B5). PATHWAY anti-HER2 (4B5) significantly reduced the number of equivocal results that require additional testing. Although HercepTest was positive in a small number of HER2 nonamplified cases, 4B5 failed to detect 3 cases that were interpreted as positive by FISH, all with nonclassic or low levels of amplification.

Antibodies, Monoclonal - metabolism

Biomarkers, Tumor - metabolism

Breast Neoplasms - diagnosis

Breast Neoplasms - genetics

Female

Gene Amplification

Humans

Immunohistochemistry - methods

In Situ Hybridization, Fluorescence

Observer Variation

Receptor, ErbB-2 - genetics

Receptor, ErbB-2 - metabolism

Reproducibility of Results

Sensitivity and Specificity

United States

United States Food and Drug Administration

Details

Title: Subtitle: Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma
Creators: Elena Lucas - Department of Pathology
Seema B Jabbar - Department of Pathology
Kyle Molberg - Department of Pathology
Yisheng Fang - Department of Pathology
Xian-Jin Xie - The University of Texas Southwestern Medical Center
Sara Blacketer - Parkland Memorial Hospital
Sunati Sahoo - Department of Pathology
Resource Type: Journal article
Publication Details: Applied immunohistochemistry & molecular morphology, Vol.27(6), pp.403-409
DOI: 10.1097/PAI.0000000000000646
PMID: 31233398
ISSN: 1541-2016
eISSN: 1533-4058
Language: English
Date published: 07/2019
Academic Unit: Preventive and Community Dentistry; Biostatistics; Dental Research
Record Identifier: 9984367723902771

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