The Prosigna Breast Cancer Prognostic Assay is a means of testing the possibility of recurrence for up to 10 years in female breast cancer patients. Approved by the U.S. Food and Drug Administration in September 2013, the test analyzes the activity of specific genes in early-stage, hormone-receptor-positive breast cancer.

By comparing results to a 58 gene signature assay, Prosigna can provide a risk category, and a numerical score, to assess the probability of breast cancer recurrence for certain female breast cancer patients.

While it cannot be used as a means of diagnosing the recurrence of breast cancer in female patients, Prosigna does allow patients to know whether they have a high or low risk of distant recurrence following five years after initial diagnosis. With this information medical practitioners are able to create a future game plan to help prevent breast cancer recurrence five to 10 years down the line.

The Prosigna test is performed on preserved tissue initially taken during an original biopsy or surgery. It can only be used on breast cancers diagnosed in postmenopausal women that fit the following criteria:

• have been treated with surgery and hormonal therapy
• show stage I or stage II and lymph node-negative
• show stage II with one to three positive nodes
• are hormone-receptor-positive
• invasive

For postmenopausal female breast cancer patients who have previously undergone surgery and locoregional treatment, Prosigna Breast Cancer Prognostic Assay can be a useful tool to help guide future treatment and monitoring strategies.