Is Prosigna the right test right for you?
If you’re a woman with early-stage, hormone-receptor-positive breast cancer, this test can help you and your clinician identify the best treatment options for you, particularly around the length of time it’s beneficial to have hormonal therapy.
It’s all about analysing your risk of distant recurrence (cancer coming back in a part of the body away from the breast) and applies if you are a postmenopausal woman within 10 years of diagnosis and with up to three positive lymph nodes after five years of hormonal therapy treatment.
If the test shows you to be low risk, it may be that hormone therapy is the only treatment you will need.
Ask your clinician how you can get this test, or download this leaflet to give to them.
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What could the Prosigna test do for you?
This test is an analysis of your tumour to see how active certain genes are as these affect how the cancer behaves including how likely it is to grow and spread.
The results, when examined together with factors such as your age, the size and grade of your cancer, whether cancer cells were found in nearby lymph nodes can enable you and your clinician make informed decisions about your treatment – taking potential side effects and quality of life into account.
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What do I have to do?
This test is an analysis of your tumour tissue. You will have had a biopsy before you received your cancer diagnosis, and we can use the sample taken at that time so you do not need an additional medical procedure to take this test.
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The process
This test is only available through your clinician, who will receive your test results directly.
Step 1 – Purchase and permission
Buy the test. You will receive an email asking you to confirm that you have authorised ELG to be given a sample of your tumour tissue.
Step 2 – Collection of sample
We will contact your pathologist directly and organise the collection of your sample and delivery to the laboratory.
Step 3 – Analysis and reporting
Your sample will be analysed and a report will be generated, usually within seven working days of receipt of your sample in the laboratory.
Step 4: Results
Your clinician will receive the test report and will then be able to make an appointment to talk through your options.
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Is this the right test for your patient?
The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) is a genomic test that analyses the activity of certain genes in early-stage, hormone-receptor-positive breast cancer.
Research suggests the test may eventually be widely used to help make treatment decisions based on the risk of distant recurrence (cancer coming back in a part of the body away from the breast) for postmenopausal women within 10 years of diagnosis of early-stage, hormone-receptor positive disease with up to three positive lymph nodes after five years of hormonal therapy treatment.
Who’s eligible for the Prosigna assay?
The Prosigna assay can only be used on breast cancers diagnosed in postmenopausal women that are:
- early breast cancer, ER+, Her 2 neg, Node Neg or Node Positive (1-3 node involvement)
- hormone-receptor-positive
- invasive
The Prosigna assay is performed on preserved tissue that was removed during the original biopsy or surgery (treatment naive).
How does the Prosigna assay work?
The Prosigna assay looks at the activity of the PAM50 gene signature to estimate the risk of distant recurrence of hormone-receptor-positive breast cancer from five to 10 years after diagnosis after five years of hormonal therapy treatment in postmenopausal women. Based on these activity levels, Prosigna assay results are reported as a risk of recurrence (ROR) score from 0 to 100 in two ways:
- node-negative cancers are classified as low (0-40), intermediate (41-60), or high (61-100) risk
- node-positive cancers are classified as low (0-15), intermediate (16-40), or high (41-100) risk
- Validation Studies
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This test is provided by:
