MammaPrint Test

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The MammaPrint test, made by Agendia, is a genomic test that analyzes the activity of certain genes in early-stage breast cancer.

Research suggests the MammaPrint test may eventually be helpful in figuring out if the cancer has a low or high risk of coming back (recurrence) within 10 years after diagnosis.

Still, all the studies done on the MammaPrint test have been retrospective studies. A retrospective study means the researchers analyzed information that was collected before the study was designed. Many doctors think that the results of retrospective studies aren’t as strong as studies that are designed first and then collect new information specifically for that study (prospective studies).

In the studies on the MammaPrint test, the researchers used the MammaPrint test on samples of breast cancer tissue that had been collected years earlier. The women were part of other studies, so the researchers already knew how many women had had a recurrence. The point of the studies was to see how accurate the MammaPrint test’s predictions were.

While the results are promising, it’s important to remember that until a prospective study is done, MammaPrint test results shouldn’t be used to make treatment decisions. This is why the MammaPrint test isn’t included in the National Comprehensive Cancer Center Network (NCCN) or the American Society of Clinical Oncology (ASCO) treatment guidelines. The NCCN is an alliance of 21 of the world's leading cancer centers. These NCCN centers collaborate on research, guidelines, and education to improve the care of people diagnosed with cancer. ASCO is a national organization of oncologists and other cancer care providers. ASCO guidelines give doctors recommendations for treatments that are supported by much credible research and experience.

In the future, a test that could help figure out whether a woman has a high or low risk of early-stage breast cancer coming back might help women and their doctors decide if chemotherapy or other treatments to reduce risk after surgery are needed.

Who's eligible for the MammaPrint test?

MammaPrint can only be used to analyze early-stage breast cancers. In the United States, MammaPrint can be used on cancers that are:

  • stage I or stage II
  • invasive
  • smaller than 5 centimeters
  • estrogen-receptor-positive or -negative 

Internationally, MammaPrint can be used on cancers that are:

  • stage I or stage II
  • invasive
  • smaller than 5 centimeters
  • in three or fewer lymph nodes

In both the United States and internationally, MammaPrint can be used to analyze cancers that are hormone-receptor-positive and hormone-receptor-negative.

The MammaPrint test can be performed on fresh or freshly frozen breast cancer tissue or tissue that has been treated or "fixed" with a special solution to preserve the genetic material. The MammaPrint test also can be done on a sample of preserved tissue that was removed during the original biopsy or surgery.

How does the MammaPrint test work?

The MammaPrint test looks at the activity of 70 genes and then calculates a recurrence score that is either low risk or high risk.

If you decide to have the MammaPrint test, you and your doctor will consider a number of factors when deciding on whether to add chemotherapy to your treatment plan, including:

  • your age
  • the size of the cancer
  • cancer grade
  • whether cancer cells were found in nearby lymph nodes
  • your general health

How is MammaPrint different from the Oncotype DX test, the Mammostrat test, and the Prosigna assay?

You may have heard about three other tests that analyze breast cancer genes to predict recurrence:

While all four tests analyze genes to help estimate the risk a cancer will come back, there are differences:

  • The Oncotype DX test is used to estimate a woman’s risk of recurrence of early-stage, hormone-receptor-positive breast cancer, as well as how likely she is to benefit from chemotherapy after breast cancer surgery. The Oncotype DX test also is used to estimate a woman’s recurrence risk of DCIS (ductal carcinoma in situ) and/or the risk of a new invasive cancer developing in the same breast, as well as how likely she is to benefit from radiation therapy after DCIS surgery. The Oncotype DX test analyzes the activity of 21 genes and then calculates a recurrence score number between 0 and 100; the higher the score, the greater the risk of recurrence.

    The OncoType DX test is the only one of these four tests that has had prospective study results published. It is also the only one of these four tests that is included in the NCCN and ASCO treatment guidelines. Because of this more rigorous research, the Oncotype DX test is the only one of these tests right now that can be used to make treatment decisions.
  • Research suggests the MammaPrint test eventually may be used to estimate a woman’s recurrence risk for early-stage breast cancer that is hormone-receptor-positive or hormone-receptor-negative. The MammaPrint test analyzes 70 genes to see how active they are and then calculates either a high-risk or a low-risk recurrence score. Still, the MammaPrint test has only been studied with retrospective research. While the results are promising, more research -- especially prospective studies -- is needed. The MammaPrint test isn’t included in the NCCN treatment guidelines, and MammaPrint results shouldn’t be used to make treatment decisions until prospective studies are completed and published.
  • Research suggests the Mammostrat test eventually may be used to estimate a woman’s risk of recurrence of early-stage, hormone-receptor-positive breast cancer. The Mammostrat test measures the levels of five genes in breast cancer cells. These measurements are used to calculate a risk index score. Women are assigned to a risk category (high, moderate, or low) based on their risk index score. Still, the Mammostrat test has only been studied with retrospective research. While the results are promising, more research -- especially prospective studies -- is needed. The Mammostrat test isn’t included in the NCCN treatment guidelines, and Mammostrat results shouldn’t be used to make treatment decisions until prospective studies are completed and published.
  • Research suggests the Prosigna assay eventually may be used to estimate the risk of distant recurrence (cancer coming back in a part of the body away from the breast) 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 in postmenopausal women. The Prosigna assay analyzes the activity of 58 genes and calculates a risk of recurrence score (low, intermediate, or high). Still, the Prosigna test has only been studied with retrospective research. While the results are promising, more research -- especially prospective studies -- is needed. The Prosigna test isn’t included in the NCCN treatment guidelines, and Prosigna results shouldn’t be used to make treatment decisions until prospective studies are completed and published.

All four tests can be done on a sample of preserved tissue that was removed from the breast during the original biopsy or surgery.

Insurance coverage for MammaPrint

Some insurance companies will pay for the total cost of the MammaPrint test, while others may pay a portion of the cost.

If you're considering the MammaPrint test, talk to your insurance company to find out if it's covered.

Agendia offers the Reimbursement Assistance Program to help with insurance and payment issues. If you don't have insurance or your insurance company doesn't cover the MammaPrint test, Agendia may still be able to help.

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