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
In recent years, new diagnostic tests have been developed to help health care professionals choose the most appropriate therapeutic strategy for their patients.
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 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.
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.
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.
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
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
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.
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
In addition to the intrinsic subtype, the Prosigna test combines tumour size, nodal status, and proliferation score when determining your risk of recurrence.
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.
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 PositiveAvg. 10yr Prob. Distant Recurrence | Range of 10 Yr Prob. DR | Node NegativeAvg. 10yr Prob. Distant Recurrence | Range of 10 Yr Prob. DR |
|---|---|---|---|---|
| Low | 8% | 5 – 7% | 4% | 0 – 7% |
| Intermediate | 10% | 7 – 15% | 11% | 7 – 15% |
| High | 28% | 15 – 70 % | 22% | 15 – 55 % |
CI: Confidence Interval
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.
Mrs. F.J., 55
Subtype: Luminal A
Prosigna Risk of Recurrence (ROR) Score: 8
Prosigna Risk Group: 5%, Low Risk
Mrs. M.T., 54
Subtype: Luminal B
Prosigna Risk of Recurrence (ROR) Score: 70
Prosigna Risk Group: 21%, High Risk
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.
Oncologist (ordering provider) requests Prosigna Breast Cancer Assay
Samples from your tumour are sent to the nCounter-enabled laboratory**
Pathologist confirms that patient meets Prosigna assay indications upon tissue review
Sample is prepared and the Prosigna assay is run on the nCounter Analysis System
Prosigna assay results are provided to the ordering provider
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:
All these recommendations reflect peer recognition of the Prosigna test and its contribution to the health of women with breast cancer.
The Prosigna Breast Cancer Assay is intended for post-menopausal patients with early-stage hormone receptor-positive (HR+, estrogene receptor)
The Prosigna test is covered by an increasing number of public healthcare systems across the world.
In Europe Prosigna is backed by leading Health Technology Assessment (HTA) agencies and/or decision makers such as:
Prosigna is also reimbursed in Denmark, Israel, Lithuania, Spain and other countries.
*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.
*** Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V5.2023. © 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 responsability for their application or use in any way. NCCN=National Comprehensive Cancer Network® (NCCN®)
