Prosigna Breast Risk of Recurrence test

The Prosigna Breast Risk of Recurrence (ROR) test is a genomic test for premenopausal and postmenopausal women with hormone receptor-positive, HER2-negative invasive breast cancer with zero to nine positive lymph nodes. Postmenopausal means that you no longer get monthly periods.

The Prosigna test was originally cleared by the FDA based on data from two clinical trials called TransATAC and ABCSG-8. These trials showed that the Prosigna results provide information about the chance of breast cancer returning in the next 10 years if you complete 5 years of hormonal therapy.

This use of the Prosigna test is part of the standard treatment guidelines for the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO). Test results can guide you and your doctor as you make treatment decisions.

More recent findings from a clinical trial called OPTIMA showed that the Prosigna test can predict who may benefit from chemotherapy and who may safely avoid it.

Who is the Prosigna test for?

The Prosigna test is for premenopausal and postmenopausal women with hormone receptor-positive, HER2-negative breast cancer that is:

• Node negative (no cancer in the lymph nodes), stage I or stage II

OR

• Node positive (cancer in up to nine lymph nodes), stage II or stage IIIA

Here are the Prosigna medical guidelines for people in the US:

• NCCN guidelines recommend the Prosigna test for understanding risk of recurrence in people with cancer in up to three lymph nodes.
• ASCO guidelines suggest that doctors use the Prosigna test to guide choices about chemotherapy in postmenopausal women with no cancer in the lymph nodes.

With the recent data from the OPTIMA trial, these guidelines are under review to expand the recommended population to include premenopausal women and patients with up to nine positive lymph nodes.

How does the Prosigna test work?

After a biopsy or lumpectomy or mastectomy surgery, your doctor can order this test. You do not have to have any additional procedures before the test. A sample of the tissue from your biopsy or surgery will be sent to a lab for Prosigna testing.

At the lab, the Prosigna test looks at the expression of 50 genes, known as the PAM50 classifier, to better understand the cancer. Expression means whether a gene is turned off or on, and how strongly it is turned on. This expression determines the cancer’s molecular subtype.

Molecular subtype describes breast cancer cell behavior based on their characteristics. These characteristics include hormone receptor status, HER2 status, how fast the cells grow, and more. The four molecular subtypes are:

• Luminal A
• Luminal B
• HER2-enriched
• Basal-like

Learn more about molecular subtypes.

The Prosigna test also looks at:

• The tumor size
• The number of lymph nodes containing cancer

This information is used to produce a number called the Risk of Recurrence (ROR) Score and estimate the chance of recurrence within 10 years if you complete 5 years of hormonal therapy. The test also identifies whether someone is predicted to benefit from chemotherapy or may safely avoid it. Your doctor can use this information to help select the best treatment for you.

Results are usually available within about 2 weeks.

What do Prosigna results mean?

Your doctor will receive a results report that shows:

• The cancer’s molecular subtype. Molecular subtype includes breast cancer cell features such as hormone receptor status and HER2 status. The breast cancer is classified as luminal A, luminal B, basal-like, or HER2 enriched.
• The Prosigna Risk of Recurrence (ROR) score. The ROR score ranges from 0-100. It is used to determine the probability of breast cancer recurrence within 10 years and whether you may benefit from chemotherapy.
• The 10-year probability of breast cancer recurrence. This estimates the likelihood that the cancer will return if you receive hormonal therapy alone.
• The predicted benefit of chemotherapy. If the ROR score is 60 or lower, chemotherapy may not be needed. If the score is higher than 60, chemotherapy may be helpful for you.

You and your doctor can use this information to decide the best treatment plan for you.

What does the research show?

To learn more about how the Prosigna test can be used and in which people, researchers conducted a phase III clinical trial called OPTIMA.

Researchers wanted to learn:

• Whether the Prosigna test can be used to predict the benefit of chemotherapy
• How it may be used in men, premenopausal women, and people with cancer in up to nine lymph nodes

The research team shared the following results of this trial at the 2026 annual ASCO meeting:

• People with hormone receptor-positive, HER2-negative invasive breast cancer with 0 to 9 positive nodes and a Risk of Recurrence (ROR) Score of 60 or lower can safely avoid chemotherapy.

Paying for Prosigna

Most private health insurance plans cover the Prosigna test.

If your health insurance does not fully pay for Prosigna, financial assistance or payment plans are available through the company that makes the test:

• The Veracyte Access Program supports eligible, uninsured, and commercially insured people with financial need.
• The company offers payment plans for people whose situations meet certain requirements.

If you have questions about the access program or payment plans, contact the Veracyte Patient Financial Navigation team:

• Email: patientfinancialservices@veracyte.com
• Phone: 888-792-1601 (press 1 to connect with Patient Financial Navigation)