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IN the US OUTSIDE the US
CONTACT US

Contact us today

Monday to Friday, 5:30 AM – 5:00 PM (PST)

Phone: 1.888.923.4762

International: +1.650.243.6335

Fax: 650.243.6388

info@prosigna.com

You are now entering a page intended for healthcare professionals only, if you are a patient or a member of the public, we will address you to a dedicated webpage.

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, which represents one in 15 women who will develop breast cancer in their lifetime.¹

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 your 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 to remove the tumour.
  • 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).²
To confidently choose the best treatment, your doctor needs to get the most accurate data

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 tumour? 

  • 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 tumour tissue to understand how they interact and function.

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 tumour, and makes it possible to learn about its tumour's distinctive biology and behaviour. 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, molecular intrinsic subtype*, proliferation status of your tumour, and your nodal status. This information is then compared to validation data of more than 2400 women with similar disease.³

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

An advanced test3, more details for a better decision

The Prosigna test analyses 50 genes, allowing for the identification of the tumours subtype*, which is important for personalized treatment.³

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.4

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 allows the determination of the subtype of your tumour: the intrinsic subtypes. These subtypes help 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 tumour.

Breast cancers can be divided into 4 subtypes with different outcomes and treatment options. Prosigna can tell you which subtype you are.

Please ask your doctor to learn more about the biology behind subtyping and what it means for you.

Determine the molecular subtype

The Prosigna algorithm³

In addition to the intrinsic subtype, the Prosigna test combines tumour 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 tumour is: low, intermediate, or high

– What your intrinsic subtype is.

Your doctor will use this information to help decide on the best treatment for you.

 

Risk classification³

ROR and nodal status are used to assign each patient to a predefined risk group that correlates with the 10-year probability of distant recurrence. These categories are different if a patient is node positive or node negative.  

Prespecified Risk Group Node NegativeAvg. 10yr Prob. Distant Recurrence Range of 10 Yr Prob. DR Node NegativeAvg. 10yr Prob. Distant Recurrence Range of 10 Yr Prob. DR
Low 4% 0 -7% 4% 0 -7%
Intermediate 11% 7 – 15% 11% 7 – 15%
High 22% 15 – 55 % 22% 15 – 55 %
CI: Confidence Interval

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 you the most information about your cancer and the risk of distant recurrence.

The Prosigna test is CE-IVD marked (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)
  • St. Gallen International Breast Cancer Consensus Panel Recommendation
  • National Institute for health and Care Excellence (NICE)
  • Spanish Society of Medical Oncology (SEOM)
  • German Gynecological Oncology Group (AGO)
  • Israel: The Israeli Ministry of Health

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 their best life for as long as they can.

Am I eligible for the Prosigna test?

  • Female
  • Post-menopausal
  • HR+
  • Surgery + Locoreglonal SoC
  • Lymph Node Negative + Stage 1 or 2 or
    Lymph Node Positive (1~3) + Stage 2 or 4

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

Where is the Prosigna test available?

Prosigna assay is covered by an increasing number of public heathcare systems across Europe

In these countries, eligible patients will not have to pay for the test. In addition, in Europe, the Prosigna assay is backed by the leading Health Technology Assessment (HTA) agencies and/or decision makers such as5:

  • France: Ministère de la Santé (Direction Générale de l’Offre de Soin), Référentiel des Actes Innovants Hors Nomenclature (RIHN).
  • Germany: Gemeinsamer Bundesausschuss (G-BA).
  • Italy: Ministero della Salute.
  • Sweden: TLV (Tandvårds- och läkemedelsförmånsverket) ordered by the Medical Products Council (MTP-rådet).
  • United Kingdom: National Institute for Health and Care Excellence (NICE).
  • Spain: Sistema Nacional de Salud.

To find out if the Prosigna assay is covered in your country and for more information on your reimbursement status or private insurance options, 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. Talk to your doctor about whether Prosigna is right for you.

*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.

References: 1. Breast cancer – WHO | World Health Organization, 2. ASCO Cancer.Net®, 3. Package insert. Prosigna® Breast Cancer Prognostic Gene Signature Assay. 2022, 4. Perou CM, et al. Molecular portraits of human breast tumours. Nature. 2000;406(6797):747-752., 5. G-BA: Gemeinsamer Bundesausschuss; HTA: health technology assessment; MTP-rådet: Det Medicintekniska Produktrådet; NICE: National Institute for Health and Care Excellence; RIHN: Référentiel des Actes Innovants Hors Nomenclature; TLV: Tandvårds- och Läkemedelsformånsverket.