ArticlePathology research international2010
Analytical Validation of a Highly Quantitative, Sensitive, Accurate, and Reproducible Assay (HERmark) for the Measurement of HER2 Total Protein and HER2 Homodimers in FFPE Breast Cancer Tumor Specimens.
Article in Pathology research international, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
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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.
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.
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Who cites it
24 citing papers in PubMed, 51 citations in OpenAlex.
- Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Trial
- Trial
- HER2 expression in breast cancer: evidence gaps and challenges.NPJ precision oncology · 2025Review
- Article
- Taking the 'low' into consideration: Discussions on redefining HER2 status in breast cancer (Review).Molecular and clinical oncology · 2025Review
- 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 classification in breast cancer cells: A new explainable machine learning application for immunohistochemistry.Oncology letters · 2023Article
- The HER2-low revolution in breast oncology: steps forward and emerging challenges.Therapeutic advances in medical oncology · 2023Review
- Water-Dispersible Carboxymethyl Dextran-Coated Melamine Nanoparticles for Biosensing Applications.ACS omega · 2022Article
- Targeted Approaches to HER2-Low Breast Cancer: Current Practice and Future Directions.Cancers · 2022Review
- HER2-low-positive breast cancer: evolution from primary tumor to residual disease after neoadjuvant treatment.NPJ breast cancer · 2022Article
- Evolution of HER2-low expression from primary to recurrent breast cancer.NPJ breast cancer · 2021Article
- Quantification of HER1, HER2 and HER3 by time-resolved Förster resonance energy transfer in FFPE triple-negative breast cancer samples.British journal of cancer · 2020Article
- Article
- Breast carcinomas with low amplified/equivocal HER2 by Ish: potential supporting role of multiplex ligation-dependent probe amplification.Journal of experimental & clinical cancer research : CR · 2017Article
- Population PBPK modelling of trastuzumab: a framework for quantifying and predicting inter-individual variability.Journal of pharmacokinetics and pharmacodynamics · 2017Article
- A novel quantitative immunohistochemistry method for precise protein measurements directly in formalin-fixed, paraffin-embedded specimens: analytical performance measuring HER2.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2017Article
- Quantitative measurement of HER2 expression in breast cancers: comparison with 'real-world' routine HER2 testing in a multicenter Collaborative Biomarker Study and correlation with overall survival.Breast cancer research : BCR · 2015Article
- HER family kinase domain mutations promote tumor progression and can predict response to treatment in human breast cancer.Molecular oncology · 2015Article
- HER3, p95HER2, and HER2 protein expression levels define multiple subtypes of HER2-positive metastatic breast cancer.Breast cancer research and treatment · 2013Article
Corrections and comments
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Authors and funding
23 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We report here the results of the analytical validation of assays that measure HER2 total protein (H2T) and HER2 homodimer (H2D) expression in Formalin Fixed Paraffin Embedded (FFPE) breast cancer tumors as well as cell line controls. The assays are based on the VeraTag technology platform and are commercially available through a central CAP-accredited clinical reference laboratory. The accuracy of H2T measurements spans a broad dynamic range (2-3 logs) as evaluated by comparison with cross-validating technologies. The measurement of H2T expression demonstrates a sensitivity that is approximately 7-10 times greater than conventional immunohistochemistry (IHC) (HercepTest). The HERmark assay is a quantitative assay that sensitively and reproducibly measures continuous H2T and H2D protein expression levels and therefore may have the potential to stratify patients more accurately with respect to response to HER2-targeted therapies than current methods which rely on semiquantitative protein measurements (IHC) or on indirect assessments of gene amplification (FISH).
Identifiers
What OpenQuestion holds
Registered trials
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.