Prosigna Breast Cancer Prognostic Gene Signature Assay
The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test), made by Veracyte, is a genomic test that analyzes 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 5 years of hormonal therapy treatment.
Knowing if a woman has a high or low risk of distant recurrence more than 5 years after diagnosis may be able to help doctors figure out whether 5 years or 10 years of hormonal therapy is better for her situation. Research has shown that taking tamoxifen for 10 years instead of 5 years can better lower the risk of recurrence and improve overall survival for many women. But if doctors knew that a woman had a low risk of distant recurrence, they might be able spare her the extra 5 years of hormonal therapy treatment.
What are genomic tests?
Genomic tests analyze a sample of a cancer tumor to see how active certain genes are. The activity level of these genes affects the behavior of the cancer, including how likely it is to grow and spread. Genomic tests are used to help make decisions about whether more treatments after surgery would be beneficial.
While their names sound similar, genomic testing and genetic testing are very different.
Genetic testing is done on a sample of your blood, saliva, or other tissue and can tell if you have an abnormal change (also called a mutation) in a gene that is linked to a higher risk of breast cancer. See the Genetic Testing pages for more information.
Who’s eligible for the Prosigna assay?
The Prosigna assay can only be used on breast cancers diagnosed in postmenopausal women that:
are stage I or stage II and lymph node-negative
are stage II with one to three positive nodes
have been treated with surgery and hormonal therapy
The Prosigna assay is performed on preserved tissue that was removed during the original biopsy or surgery.
How does the Prosigna assay work?
The Prosigna assay looks at the activity of 50 genes (called the PAM50 gene signature) to estimate the risk of distant recurrence of hormone-receptor-positive breast cancer from 5 to 10 years after diagnosis after 5 years of hormonal therapy treatment in postmenopausal women. Based on these activity levels, Prosigna assay results are reported as a Prosgina score from 0 to 100:
node-negative cancers are classified as low (0-40), intermediate (41-60), or high (61-100) risk
node-positive cancers are classified as low (0-40) or high (41-100) risk
If you decide to have the Prosigna assay, you and your doctor will consider a number of factors when deciding whether to continue hormonal therapy for 5 more years, including:
the size of the cancer
whether cancer cells were found in nearby lymph nodes
any treatment side effects
Insurance coverage for the Prosigna assay
Some insurance companies will pay for the total cost of the Prosigna assay, while others may pay a portion of the cost.
If you and your doctor are considering the Prosigna assay, talk to your insurance company to find out if it’s covered.
— Last updated on February 10, 2022, 1:20 AM