ArticleVirchows Archiv : an international journal of pathology2022
Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status.
Article in Virchows Archiv : an international journal of pathology, 2022. 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.
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Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Consensus Guidelines on Human Epidermal Growth Factor Receptor 2 (HER2)-Low Testing in Breast Cancer in Malaysia.Cancers · 2024Guideline
- Trastuzumab deruxtecan for human epidermal growth factor receptor 2-low advanced or metastatic breast cancer: recommendations from the Japanese Breast Cancer Society Clinical Practice Guidelines.Breast cancer (Tokyo, Japan) · 2024Guideline
- Post Hoc Analysis of the Phase II DESTINY-PanTumor02 Study: Local and Central HER2 IHC Concordance and Trastuzumab Deruxtecan Efficacy by HER2 IHC Status in HER2-Expressing Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Clinical characterization, prognostic, and predictive values of HER2-low in patients with early breast cancer in the PALLAS trial (ABCSG-42/AFT-05/BIG-14-13/PrE0109).Breast cancer research : BCR · 2024Trial
- [Clinicopathological characteristics of human epidermal growth factor receptor-2 1+ cases in breast cancer].Revista medica del Instituto Mexicano del Seguro Social · 2026Observational
- HER2-low breast cancer in routine practice: a nationwide study of diagnostic variability across pathology laboratories.Virchows Archiv : an international journal of pathology · 2026Article
- Dual-block HER2 assessment reveals clinically relevant intratumoral heterogeneity in gynecologic cancers: a single-center landscape analysis.Journal of translational medicine · 2026Article
- Chimeric Anti-Glypican 1 Antibodies Exert Antitumor Activities in Xenograft Models of Lung and Pancreatic Cancers.International journal of molecular sciences · 2026Article
- Repurposing HER2 IHC: Pan-HER2 and Low-HER2.Applied immunohistochemistry & molecular morphology : AIMM · 2026Review
- Comparison of immunohistochemical HER2 low detection in breast cancer using two antibodies assays in an interlaboratory study.Virchows Archiv : an international journal of pathology · 2026Article
- Clinicopathological characteristics and prognostic significance of HER2 status evaluation in patients with urothelial carcinoma: a retrospective single-center experience in China.Virchows Archiv : an international journal of pathology · 2026Article
- HER2 Heterogeneity in Breast Cancer: Biological Basis, Clinical Implications, and Therapeutic Strategies.Breast cancer (Dove Medical Press) · 2026Review
- HER2-Low and HER2-Ultralow Metastatic Breast Cancer and Trastuzumab Deruxtecan: Common Clinical Questions and Answers.Cancers · 2025Review
- Quantification of HER2-low and ultra-low expression in breast cancer specimens by quantitative IHC and artificial intelligence.Journal of pathology informatics · 2025Article
- New standards in HER2-low testing: the CASI-01 comparative methods study.EBioMedicine · 2025Article
- Changes in HER2low and HER2-ultralow status in 47 advanced breast carcinoma core biopsies, matching surgical specimens, and their distant metastases assessed by conventional light microscopy, digital pathology, and artificial intelligence.Breast cancer research and treatment · 2025Article
- Challenges & recommendations for identification of human epidermal growth factor receptor -2 (HER2)-low metastatic breast cancer in India: Expert opinion statement.The Indian journal of medical research · 2025Review
- HER2-Low Breast Cancer-Current Knowledge and Future Directions.Medicina (Kaunas, Lithuania) · 2025Review
- Interobserver consistency and diagnostic challenges in HER2-ultralow breast cancer: a multicenter study.ESMO open · 2025Article
- Exploring the heterogeneity of HER2 gene status and expression in non-positive breast cancer patients: insights from immunohistochemistry and fluorescence in situ hybridization.Diagnostic pathology · 2025Article
Corrections and comments
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Authors and funding
12 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Performance of the new CE-IVD-marked HercepTest™ mAb pharmDx (Dako Omnis) assay (HercepTest (mAb)) was compared against the PATHWAY® anti-HER-2/neu (4B5) (PATHWAY 4B5) assay using 119 pre-selected breast cancer samples covering the entire range of HER2 immunohistochemistry (IHC) expression scores (0, 1 + , 2 + , 3 +). The sensitivity and specificity of both assays were assessed based on consensus IHC scores and amplification status, as determined by fluorescence in situ hybridization (FISH) according to 2018 ASCO/CAP testing guidelines. There was a high concordance between results from the HercepTest (mAb) and PATHWAY 4B5 assays for HER2-negative (IHC 0, 1 + , 2 + and FISH negative) and HER2-positive (IHC 3 + , 2 + and FISH positive) breast carcinomas (98.2%). Regarding individual IHC scores, complete agreement was achieved in 69.7% (83/119) of cases, and all but one of the discordant cases were due to higher HER2-status scoring using the HercepTest (mAb). Thus, more tumors were overscored as IHC 2 + by HercepTest (mAb) (27 versus 15) as evidenced by their lower FISH positivity rate (48.1% versus 80%). However, two amplified tumors identified as IHC 2 + by HercepTest (mAb) were missed by PATHWAY 4B5 (IHC 1 +). Four additional cases identified as IHC 2 + by HercepTest (mAb), with FISH ratio < 2 but elevated gene counts (≥ 4 to < 6), were recorded negative by PATHWAY 4B5. The HercepTest (mAb) detects HER2 expression with higher sensitivity in tumors with gene amplification (ISH group 1) and increased gene counts (ISH group 4) as well as in HER2-low tumors (HER2 IHC2 + /FISH negative or IHC 1 +). Future studies will demonstrate whether this translates into improved patient selection especially for new HER2-directed therapies.
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