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IN the US OUTSIDE the US
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My breast cancer diagnosis

Prosigna and Veracyte can give the best information for breast cancer treatment decisions.

Breast cancer is the most prevalent cancer in women, with an increasing incidence in the last 5 years. In 2020, 2.3 million women worldwide were diagnosed, including more than 264,000 in the United States1, which represents one in 15 women who will develop breast cancer in their lifetime.²

What is my breast cancer journey?

  • Screening or symptomatic presentation
    • Breast exam
    • Mammogram
  • Confirmed diagnosis
    • Medical history
    • Physical examination
    • Imaging
    • Biopsies
  • Genomic testing on tumor sample
    • Prosigna test result
  • Discussion with my doctor about treatment options
    • Radiotherapy
    • Endocrine (hormone) therapy
    • Chemotherapy
    • Targeted biologic therapy (antibodies)

What are the different types of treatment I could be offered?

Breast cancer treatment generally consists of three elements:

  • Surgery may be carried out to remove the tumor.
  • Radiotherapy to try to control the disease in the breast, lymph nodes and surrounding areas. Lymph nodes are small, rounded organs located throughout the body. Lymph is a biological fluid containing many cells involved in the body’s defense, including leukocytes or white blood cells.
  • Systemic therapy given orally or intravenously to treat and/or reduce the risk of the cancer spreading. Some examples of anti-cancer medicines include endocrine (hormone) therapy, chemotherapy and in some cases targeted biologic therapy (antibodies).³
To confidently choose the best treatment for you, your doctor needs to get the most accurate data.
read our brochure

In recent years, new diagnostic tests have been developed to help health care professionals choose the most appropriate therapeutic strategy for their patients.

What are the newest types of science that can help give an accurate picture of my tumor?

  • Genetic tests

    The sequencing of the human genome was a landmark scientific achievement and the information obtained is changing medical practice. For cancer treatment, this new knowledge has allowed development of tests that give better understanding of the biology of a breast cancer.

  • Genomic tests

    Genomic Tests examine the activity of a set of genes by extracting genetic material called RNA from the cancer tissue. By measuring the activity of the genes, patterns of gene expression can help evaluate how great the risk is that the cancer will become life-threatening. This information can be especially useful for guiding medical management on a personalized basis.

Genomic testing allows the analysis and evaluation of tumor tissue genes to understand how they interact and function.
view our video

The interpretation of gene expression profiles can help healthcare providers assess if your early breast cancer is likely to come back after an initial treatment.

Gene expression profiling: personalized signature to adapt your treatment decision

Scientific breakthroughs now allow gene expression profiling. But what does this mean?
New tests, validated by appropriate clinical studies, show gene activity in your tumor, and makes it possible to learn about its tumor's distinctive biology and behavior. The more comprehensive and accurate this information is, the more personalized and effective your treatment will be.

What is the Prosigna test?

My personalized breast test
Choose the test with proven prognostic performance

How the Prosigna test works

The Prosigna test provides information about your Risk of Recurrence (ROR) based on the size of your tumor, the molecular subtype*, the proliferation status of your tumor, and your nodal status. This information is then compared to validation data of more than 2400 women with similar disease.4

The prosigna test was developed to help your doctor assess which treatment is the most suitable for your profile.
read our brochure

An advanced test5, more details for a better decision

The Prosigna test analyses 50 genes, which is important for personalized treatment.

This test is based firstly on the determination of a gene expression profile as explained above. The Prosigna test is based on the analysis of a gene signature developed over many years of research, the PAM50 signature.6

But how can the PAM50 signature help me?

Thanks to a precise and reproducible analysis of the activity of 50 genes in the PAM50 signature, the Prosigna test helps to confidently choose a personalized treatment plan that best fits each personal situation.

PAM50: Predictor Analysis of Microarray 50, is the name of the signature used for the Prosigna test, which analyses 50 genes to classify your tumor.

Determine the molecular subtype
The Prosigna test is the only breast cancer prognostic test, developed from groundbreaking research into the four PAM50 intrinsic subtypes.
view our video

The Prosigna algorithm4

In addition to the intrinsic subtype, the Prosigna test combines tumor size, nodal status, and proliferation score when determining your risk of recurrence.

  • Determine the molecular subtype
  • Combine tumor size, nodal status and proliferation score
  • Estimate 10-year risk of distant recurrence on endocrine therapy alone

Prosigna supports the right treatment choice by providing more comprehensive information on top of the standard risk assessment.

These factors are combined and analyzed to give a score between 0 and 100, the ROR (Risk of Recurrence). This is not a percentage, just a numerical value.

This is then compared to thousands of other people with a similar type of disease, and presented in a report that tells, along with the ROR score:

– What is the percentage risk of having a recurrence in 10 years

– What is the category of your tumor is: low, intermediate, or high

The doctor will use this information to recommend the most suitable personalized treatment.

My Prosigna report

The Prosigna report provides relevant information to you and your doctor, and each report is customized to contain test results and interpretive information specific to each patient. 

Thousands of patients around the world have already chosen to use the Prosigna test. This test has allowed them to adapt their treatment, to choose with their doctor what is right for them. 

The Prosigna test provides more comprehensive information about breast cancer and the risk of distant recurrence and enables doctors to define a personalized and precise treatment plan.

When and how my Prosigna test is performed?

After surgery Prosigna test does not require any additional steps on your part and is performed in local laboratories, allowing a quick result in as little as 72 hours.

  • Prosigna Request

    Oncologist (ordering provider) requests Prosigna Breast Cancer Assay

  • Tissue Sample

    Samples from your tumour are sent to the nCounter-enabled laboratory**

  • Tissue Review

    Pathologist confirms that patient meets Prosigna assay indications upon tissue review

  • RNA Analysis

    Sample is prepared and the Prosigna assay is run on the nCounter Analysis System

  • Prosigna Report

    Prosigna assay results are provided to the ordering provider

Why should I consider this test?

Veracyte and the scientific community developed the Prosigna test to help patients and their doctors make appropriate treatment decisions. Because we understand how crucial the test results are in your journey, we are constantly working to generate further data and scientific understanding.

Choose the test clinically validated in thousands of patients with proven prognostic performance that gives the most information about a breast cancer and the risk of distant recurrence.

The Prosigna test is 510k FDA cleared (which means it is reproducible and gives accurate results) for post-menopausal women with early-stage, hormone receptor positive breast cancer. 

It therefore has the necessary approvals and authorizations proving its compliance with the rules and laws relating to the manufacture and marketing of in vitro diagnostic tests. 

The test is also approved and endorsed by numerous international recommendations and organizations such as:

  • American Society for Clinical Oncology (ASCO)
  • European Society for Clinical Oncology (ESMO)
  • National Comprehensive Cancer Network® (NCCN®)***
  • St. Gallen International Breast Cancer Consensus Panel Recommendation
  • National Institute for health and Care Excellence (NICE)

All these recommendations reflect peer recognition of the Prosigna test and its contribution to the health of women with breast cancer.

The Prosigna test gives the confidence to help women make the right choices to live your best life for as long as you can.
read our brochure

Am I eligible for the Prosigna test?

  • Female
  • Post-menopausal
  • HR+
  • Surgery + Locoreglonal SoC
  • Lymph Node Negative + Stage I or II or
    Lymph Node Positive (1-3) + Stage II

The Prosigna Breast Cancer Assay is intended for post-menopausal patients with early-stage hormone receptor-positive (HR+, estrogen receptor)

Is the Prosigna test covered by health insurance?

Prosigna assay is covered by Medicare and commercial payers for patients meeting the indications for use.

To learn more about Prosigna Breast Cancer Assay’s commercial coverage, please get in touch with your doctor or Veracyte.

Today breast cancer patients can learn more about how their care can be optimized by their doctor, confidently adapting their treatment strategy to their personal situation. You can choose with your doctor the test with proven prognostic performance that gives the most information about your cancer and the risk of distant recurrence.

*Intrinsic molecular subtypes are intended for physicians practicing outside of the U.S and are not reported by the Prosigna assay cleared by the FDA in the United States.
**nCounter is the registered trademark of NanoString Technologies used by Veracyte under license.

 

*** Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023. © National Comprehensive Cancer Network, Inc. 2023.  All rights reserved.  Accessed [December 5, 2023].  To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. NCCN=National Comprehensive Cancer Network® (NCCN®)

References: 1. U.S. Cancer Statistics Working Group. U.S. Cancer Statistics Data Visualizations Tool, 2. Breast cancer – WHO | World Health Organization, 3. ASCO Cancer.Net®, 4. Prosigna [Package Insert]. Seattle, WA: NanoString Technologies, Inc; 2013, 5. Prosigna [IVD Package Insert] Seattle, WA: NanoString Technologies, Inc; 2019-09 LBL-C0223-07. 6. Perou CM, et al. Nature 2000;406(6796):747–752