The MammaPrint® Test, a Tumor Profiler

Gene expression tests can be a very good way to learn more about your particular form of breast cancer. Based on the information these tests provide, your doctor can then decide how best to treat your cancer, or even choose no further treatment after surgery.

Gene expression tests are not the same thing as genetic testing, which is done using a sample of blood, saliva, or other tissue. Genetic testing is generally carried out to ascertain whether a person has a mutation (abnormal change) in a gene that is linked to a higher risk of breast cancer, such as BRCA1/2.

The MammaPrint test is one such gene expression test, also known as a tumor profiler. It was created by Agendia, a privately-held company in Amsterdam that develops and markets genomic diagnostic products.

How the MammaPrint test works

After you have had your breast cancer surgery or a biopsy, some tissue from the tumor is sent for examination. They look at the activity level of 70 different genes known to be associated with breast cancer. After examining the tissue, a recurrence score is then calculated which will tell whether you are at low risk or high risk for recurrence. Based on that information, your doctor can then decide whether any further treatments would be beneficial to you after surgery.

The Best Candidates for the MammaPrint Test

those with stage I or stage II breast tumors
those with invasive tumors
those whose tumors are smaller than 5 cm
those who had cancer cells in three or fewer lymph nodes
those with both hormone-receptor-positive or hormone-receptor-negative tumor cells
the tissue must be taken during the original biopsy or surgery

There are several other tumor profiling tests used to analyze breast cancer, including the Oncotype DX test, which has been validated by more research. The Oncotype DX test is presently the most widely used genomic test for breast cancer.

What is the Cost?

In the United States, the cost of the MammaPrint test ranges between USD$3,000 to $4000. It is covered by US Medicare and some private health insurance, depending on whether the individual’s breast cancer matches the test’s parameters. Be sure to ask your health insurance company if you are covered, should you be considering having the MammaPrint test.

Also, be aware that Agendia offers a reimbursement assistance program to help you with your insurance claim. If you don’t have insurance or your insurance company doesn’t cover the MammaPrint test, Agendia may still be able to help. Contact one of their patient advocate representatives by phone at 1-888-363-7868 or email at billing@agendia.com.

Unfortunately, in Australia, the Medical Services Advisory Committee (MSAC) did not support public (government) funding for the MammaPrint test. They based that decision on a review of the safety, clinical effectiveness and cost effectiveness of the test.

According to an Australian government website [1], “MSAC based its conclusion on its appraisal of a study known as the MINDACT trial which investigated the use of the MammaPrint® test in a clinical trial setting.

The trial aimed to show whether information provided by the MammaPrint® test could be added to existing clinical information to inform decisions about the use of adjuvant chemotherapy for early breast cancer. The trial showed that, overall, breast cancer outcomes were poorer in women who did not have chemotherapy based on the MammaPrint® test, compared with those who received chemotherapy.

“As a result, MSAC had little confidence that the MammaPrint® test could be used to justify withholding chemotherapy without negatively impacting upon important outcomes, including overall survival.

The MammaPrint test is available to Australia patients, but patients must pay the cost of it themselves, there are no government subsidies.

MammaPrint Research

We do have quite a bit of research [2], [3], [4], [5], [6], [7] on the MammaPrint test, which suggests that it may be useful to help make treatment decisions based on the expression of certain genes, as to the risk of the cancer returning within 10 years after diagnosis.

One 2019 review of medical studies [8] found that all of the tests analyzed (including MammaPrint) were able to provide prognostic information on the risk of relapse, but that the results were more varied in those patients with positive lymph nodes than for those with node-negative disease.

If you have been diagnosed with early-stage breast cancer and are trying to decide whether or not adding chemotherapy to your treatment plan would be beneficial, the MammaPrint test may be of very real assistance to help you and your doctor make that decision.

References:

[1] https://breast-cancer.canceraustralia.gov.au/treatment/mammaprint-70-gene-signature-test/questions-patients-about-mammaprint

[2] 2016: Special Plenary Session: Results of the MINDACT Clinical Trial – http://winconsortium.org/files/O4.5-SPECIAL-PLENARY-SESSION-Results-of-MINDACT-clinical-trial-Suzette-Delaloge.pdf
[3] 2017: The Era of Multigene Panels Comes? The Clinical Utility of Oncotype DX and MammaPrint – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5649994/
[4] 2019: MammaPrint and BluePrint Molecular Diagnostics Using Targeted RNA Next-Generation Sequencing Technology – https://www.ncbi.nlm.nih.gov/pubmed/31173928
[5] 2019: Multigene expression signatures in early hormone receptor positive HER 2 negative breast cancer – https://www.ncbi.nlm.nih.gov/pubmed/31553709
[6] 2019: Prospective, multicenter study on the economic and clinical impact of gene-expression assays in early-stage breast cancer from a single region: the PREGECAM registry experience – https://www.ncbi.nlm.nih.gov/pubmed/31300934
[7] 2019: Prospective Validation of a Genomic Assay in Breast Cancer: The 70-gene MammaPrint Assay and the MINDACT Trial – https://www.ncbi.nlm.nih.gov/pubmed/31264430

 

[8] Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer: a systematic review and economic analysis – https://www.ncbi.nlm.nih.gov/pubmed/31264581

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