ArticleBMC cancer2014
Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens.
Article in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 162 papers, 1 of them a synthesis that pooled it.
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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
162 citing papers in PubMed, 1 synthesis or guideline pooled it.
- What Do We Have to Know about PD-L1 Expression in Prostate Cancer? A Systematic Literature Review. Part 3: PD-L1, Intracellular Signaling Pathways and Tumor Microenvironment.International journal of molecular sciences · 2021Pooled it
- The spatially informed mFISHseq assay resolves biomarker discordance and predicts treatment response in breast cancer.Nature communications · 2025Trial
- Triple-Negative PAM50 Non-Basal Breast Cancer Subtype Predicts Benefit from Extended Adjuvant Capecitabine.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Trial
- Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419).Radiation oncology (London, England) · 2020Trial
- Research-based PAM50 signature and long-term breast cancer survival.Breast cancer research and treatment · 2020Trial
- Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2019Trial
- Trial
- An international reproducibility study validating quantitative determination of ERBB2, ESR1, PGR, and MKI67 mRNA in breast cancer using MammaTyper®.Breast cancer research : BCR · 2017Trial
- Genomic markers of panitumumab resistance including ERBB2/ HER2 in a phase II study of KRAS wild-type (wt) metastatic colorectal cancer (mCRC).Oncotarget · 2016Trial
- Normalization of nCounter Gene Expression Data Alters Molecular Diagnostics in Kidney Transplantation.Journal of the American Society of Nephrology : JASN · 2026Article
- Transcriptome-Based Synthetic Lethality Predictions to Improve Targeted Therapy/Immunotherapy Treatment Prioritization in Nonmetastatic Breast Cancer: BC-SELECT.Cancer research communications · 2026Article
- Comparison of a Novel MRNA-Based Breast Cancer Subtyping Assay with PAM50 and Oncotype DX in Estrogen Receptor-Positive/HER2-Negative Breast Cancer: An Exploratory Age-Stratified Retrospective Cohort Study.Current issues in molecular biology · 2026Article
- Quantum Computing in a Diagnostic-First Quantum Residual Boosting Framework for Clinical Survival Analysis in Oncology and Cardiology.Journal of clinical medicine · 2026Article
- The MHCII Immune Activation Score predicts risk of recurrence and benefit of taxanes in Basallike and HER2-enriched breast cancer.medRxiv : the preprint server for health sciences · 2026Article
- Optimizing transcriptome-based synthetic lethality predictions to improve targeted therapy / immunotherapy treatment prioritization in non-metastatic breast cancer: BC-SELECT.bioRxiv : the preprint server for biology · 2026Article
- RNA Detection Technologies: A MethodCentric Guide to Principles and Reproducibility.Bio-protocol · 2026Article
- Bioorthogonal Click Chemistry-Enabled Enrichment of Extracellular Vesicles for Integrated Molecular and Functional Liquid Biopsy§.Accounts of chemical research · 2026Article
- CorePAM: a 24-gene PAM50-derived expression score with cross-platform external validation for breast cancer prognosis.Breast cancer research : BCR · 2026Article
- Genetic diversity of collaborative cross mice enables the establishment of a novelInfection and immunity · 2026Article
102 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNanoString's Prosigna™ Breast Cancer Prognostic Gene Signature Assay is based on the PAM50 gene expression signature. The test outputs a risk of recurrence (ROR) score, risk category, and intrinsic subtype (Luminal A/B, HER2-enriched, Basal-like). The studies described here were designed to validate the analytical performance of the test on the nCounter Analysis System across multiple laboratories.
methodsAnalytical precision was measured by testing five breast tumor RNA samples across 3 sites. Reproducibility was measured by testing replicate tissue sections from 43 FFPE breast tumor blocks across 3 sites following independent pathology review at each site. The RNA input range was validated by comparing assay results at the extremes of the specified range to the nominal RNA input level. Interference was evaluated by including non-tumor tissue into the test.
resultsThe measured standard deviation (SD) was less than 1 ROR unit within the analytical precision study and the measured total SD was 2.9 ROR units within the reproducibility study. The ROR scores for RNA inputs at the extremes of the range were the same as those at the nominal input level. Assay results were stable in the presence of moderate amounts of surrounding non-tumor tissue (<70% by area).
conclusionsThe analytical performance of NanoString's Prosigna assay has been validated using FFPE breast tumor specimens across multiple clinical testing laboratories.
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