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GTR Home > Tests > Prosigna™ Breast Cancer Prognostic Gene Signature


Test name


Prosigna™ Breast Cancer Prognostic Gene Signature (Prosigna™)

Purpose of the test


This is a clinical test intended for Help: Prognostic, Recurrence, Therapeutic management



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Click Indication tab for more information.

How to order


Outside the USA: 1.- Complete the Requisition Form for Prosigna Assay 2.- Check the box to enssure the understanding of the Prosigna assay indications 3.- A pathologist requisition form is also needed to obtain the patient's specimen 4.- The informed consent of the patient has to be signed 5.- The patient´s result will be sent to the ordering physician For further information, please, contact to Oncogenomics SL at info@oncogenomics.com or directly to the laboratory at oncolab@iisgm.com
Order URL Help: http://www.oncogenomics.es/servicios/que-es-prosigna

Specimen source

Paraffin block


Molecular Genetics
RRNA analysis
Gene expression profiling
  • nCounter Dx Analysis System - Nanostring Inc.
  • nCounter Dx Analysis System

Summary of what is tested

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Click Methodology tab for more information.

Clinical utility


Guidance for management

  • Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor positive, human epidermal growth factor receptor negative, node negative early-stage breast cancer. - PubMed ID: 25851308

Clinical validity


Two clinical validation studies were executed to validate the Prosigna Breast Cancer Prognostic Gene Signature Assay. The Prosigna assay reports an ROR score (0–100), an intrinsic subtype (Luminal A, Luminal B, HER2-enriched or Basal-like) and risk categorization (Low, Intermediate, or High) for each tumor sample. The primary objective of both studies was to validate published observations that the risk of recurrence score (ROR) provides additional prognostic information for distant recurrence free survival at 10 years over and above standard clinical variables. Also, a secondary objective from both studies aimed to validate previous observations that Luminal A and Luminal B patients have statistically significantly different distant recurrence-free survival at 10 years. Because the entry criteria and results of these two studies were similar, the two databases were combined and analyzed with a prospectively defined analysis plan that had the same objectives as the individual studies. Results are generalizable for distributed use as samples were sent to and analyzed in different labs in the two clinical validation studies. The ROR was demonstrated to add significant prognostic information for 10 year distant recurrence-free survival (DRFS) over and above the standard clinical and treatment variables, both when included as a continuous measure and when included using three pre-defined risk groups. Additionally, in a post-hoc analysis, the ROR added significant information for post 5-years DRFS over and above standard clinical variables for all patients. The ROR (continuous and risk-group based) showed similar prognostic information in various subgroups. Limited analyses were also performed using recurrence-free survival (RFS). The ROR classes were also able to define three risk groups with distinct RFS. For both studies, there were significant differences between the DRFS of Luminal A and Luminal B subgroups, independent of nodal status. The Prosigna™ assay for invasive breast cancer is acknowledged as having achieved tumor marker level 1B evidence for its prognostic value for clinical use. The Prosigna™ assay for invasive breast cancer has been incorporated into major oncology clinical guidelines (NCCN®, St Gallen, ESMO®).

  • Tamoxifen and anastrozole as a sequencing strategy: a randomized controlled trial in postmenopausal patients with endocrine-responsive early breast cancer from the Austrian Breast and Colorectal Cancer Study Group. - PubMed ID: 22271481
  • Comparison of PAM50 risk of recurrence score with oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. - PubMed ID: 23816962
  • Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. - PubMed ID: 24347518
  • nCounter(®) PanCancer Immune Profiling Panel (NanoString Technologies, Inc., Seattle, WA). - PubMed ID: 26674611

Suggested reading

  • Cardoso et al., 2016
  • Ward et al., 2013
    Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis.

Clinical resources

Practice guidelines

  • NICE, 2024
    UK NICE Guideline NG101, Early and locally advanced breast cancer: diagnosis and management, 2024
  • NCCN, 2023
    Breast Cancer, NCCN Guidelines Version 4.2022
  • NCCN, 2022
    Breast Cancer Screening and Diagnosis, NCCN, Version 1.2022
  • NICE, 2018
    Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (DG34)
  • NICE, 2018
    Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer, NICE, 2018
  • NCCN, 2014
    National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Breast Cancer (See 2022 Update)
  • NICE, 2013
    DG10 Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat: information for the public
  • AHRQ, 2013
    Technology Assessment on Genetic Testing or Molecular Pathology Testing of Cancers with Unknown Primary Site to Determine Origin (ARCHIVED)
  • NCCN, 2011
    NCCN Task Force report: Evaluating the clinical utility of tumor markers in oncology.

Consumer resources

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.