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info@prosigna.com

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Discover new educational tools to help you inform your patients about the Prosigna® Breast Cancer Assay
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Choose the test with proven prognostic performance

The Prosigna assay, designed from the foundations of breast cancer biology, provides the confidence to help make the right choices.

The need for greater prognostic performance

Knowing and being confident in the measurement of recurrence risk is an important consideration for deciding which treatment to recommend in ER+/HER2- breast cancer.1

The Prosigna Breast Cancer Assay is intended for post-menopausal women with early-stage HR+/HER2- breast cancer.

The Prosigna prognostic gene signature assay is a 2nd generation test that has shown improved performance when compared with older genomic assays.

The Prosigna risk of recurrence (ROR) score adds significant prognostic information to conventional risk factors such as pathological analysis of the patient tumor, and protein markers detected using immunohistochemistry.2

More comprehensive information on the risk of recurrence

The Prosigna® Breast Cancer Prognostic Gene Signature Assay reports two key pieces of information specific to your patient:

  1. Risk Group (Low, Intermediate, High)
  2. Risk of Recurrence (ROR) Score

Prosigna ROR score provides more accurate prognostic information on the risk of distant recurrence among gene-expression and immunohistochemical biomarkers.2

The Prosigna assay accurately classifies patients into low, intermediate, or high risk of distant recurrence.

In a real-world setting, the Prosigna assay reliably identified low risk patients that were either node-negative or had one to three positive nodes, which could help clinicians decide if a patients could safely avoid adjuvant chemotherapy.3

Extensive global evidence of clinical validity and clinical utility in over 5,200 patients treated with 5 years of standard-of-care hormone therapy and 10 year follow-up (prospective and populational).

The ABCSG-8 study performed a retrospective-prospective analysis of 1378 postmenopausal patients with node negative and positive early stage breast cancer treated only with endocrine therapy.

Low and high risk differentiation is a key factor for determining a confident treatment decision

In a real-world setting, the Prosigna assay reliably identified low risk patients that were either node-negative or had one to three positive nodes, which could help clinicians decide if a patients could safely avoid adjuvant chemotherapy.3 The Danish Breast Cancer Cooperative Group (DBCG) examined distant recurrences in a comprehensive nationwide cohort consisting of 2,558 postmenopausal women with hormone receptor-positive early breast cancer treated with 5 years of endocrine therapy alone.3

The Prosigna ROR score more accurately estimated the probability of 10-year distant recurrence in this population compared with the risk stratification provided by other gene panels.3.4

An accurate prognosis is the foundation of long-term treatment recommendations

Identify patients that can safely avoid over-treatment

The transATAC study is a correlative tissue-based analysis of the performance of gene expression profiling tests in a subset of 1007 patients in the ATAC trial treated with endocrine therapy only.

The recurrence risk results of more than a half (59%) patients in sub-analysis of 663 of the original 774 samples within the TransATAC study were discordant between Prosigna and Oncotype Dx. The observed outcomes were more consistent with the Prosigna risk category, not the Oncotype DX risk category.6,7

The Prosigna assay provides accurate prognostic information

Uniquely designed to inform treatment decisions

The Prosigna gene expression assay is the only breast cancer prognostic test developed from the four PAM50 intrinsic subtypes.8

In addition to the intrinsic subtype, the Prosigna assay combines tumor size, nodal status and proliferation score to determine the 10-year risk of recurrence (ROR) score.9

  • Determine Gene Expression through Pearson’s Correlation to Centroids
  • Calculate Prosigna Score
  • Estimate 10-Year Risk of Distant Recurrence on Endocrine Therapy Alone

Guideline Recommendations

Prosigna® Breast Cancer Prognostic Gene Signature Assay (Prosigna assay) for use on the nCounter® Analysis System is 510(k) cleared for in vitro diagnostic use in prognosis and surgical resection. Please refer to region specific Package Inserts for the respective product claims. Intrinsic molecular subtypes are not reported by the Prosigna assay cleared by the FDA in the United States. However, intrinsic molecular subtypes identified by the gene signature are utilized by the algorithm to calculate the Prosigna Score (ROR) and risk category.

 

Prosigna® in conjunction with the nCounter® Analysis System is 510(k) FDA cleared for in vitro diagnostic use in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer and post-menopausal women with Hormone Receptor-Positive (HR+), lymph node positive (1–3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy. See Package Insert for further details at prosigna.com. ©2021 Veracyte, Inc. Prosigna and the Prosigna logo are trademarks and/or registered trademarks of Veracyte, Inc. in various jurisdictions.

 

National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN. ASCO and ESMO are trademarks of the American Society of Clinical Oncology and European Society for Medical Oncology. NCCN, National Institute for Health and Care Excellence (NICE), St Gallen International Consensus Panel, ASCO and ESMO do not endorse any product or therapy.

 

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Guideline Name V.2.2021 and V.4.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed April 24, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

Prosigna Patient Profiles

Your Prosigna Assay Patient

A simple ordering process

Prosigna Assay results may be available in as little as 72 hours


  • To order the Prosigna Prognostic Gene Signature Assay
    please contact Veracyte at orders@veracyte.com


  • To re-order the Prosigna Prognostic Gene Signature Assay Kit
    please contact Veracyte at orders@veracyte.com


  • To order the nCounter® Analysis System for your site
    please contact Veracyte at orders@veracyte.com

References: 1. Alexandre M, et al. Cancer Manag Res. 2019;11:10353–10373. 2. Sestak I, et al. JAMA Oncol. 2018;4(4):545–553. 3. Lænkholm AVet al. J Clin Oncol. 018;10;36(8):735-740. 4. Costa et al. J Clin Oncol. 2018;10;36(8):725-727. 5. Gnant M, et al. Ann Oncol. 2014;25(2):339-45.6. Dowsett M, et al. J Clin Oncol. 2013;31(22):2783-2790. 7. Prosigna [IVD Package Insert] Seattle, WA: NanoString Technologies, Inc; 2019-09 LBL-C0223-07. 8. Parker JS, et al. J Clin Oncol. 2009;27(8):1160-1167. 9. Perou M, et al. Nature 2000; 406(6796):747–752 10. Cejalvo JM et al.Cancer Treat Rev. 2018 Jun;67:63-70. 11. Goldhirsch A, at al. Annals of Oncology 2013;24: 2206–2223.