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About MammaPrint

Overview

Assessing the risk of your breast cancer recurring

After being diagnosed with cancer, your doctors will do everything to remove all breast cancer tumor cells from your body. But for some women, breast cancer might come back (recur) months or even years later. If your breast cancer was judged to be a primary tumor, your physician needs to assess the risk of that breast cancer developing metastases in the following years before deciding on the optimal follow-on treatment.

Tumors can vary from one to the other. These differences can only be detected by looking inside the cancer cells. MammaPrint® is a test that uses gene expression profiling to analyze the genetic makeup of the tumor itself, looking at the activity of 70 genes. This information indicates if a tumor is likely to spread or not, providing a clearer picture of your risk (low or high) for cancer recurrence within the next 10 years. This result, together with other parameters, can provide valuable insight for doctors to personalize your medical care – helping them decide on an appropriate treatment plan that is right for you.


Determining the risk of breast cancer recurrence – results within 10 days

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Development

Development of the MammaPrint Profile

The first peer-reviewed publication presenting the MammaPrint 70-gene expression profile as a predicator of survival in breast cancer appeared in 2002 and was closely followed by an independent validation study published the New England Journal of Medicine in the same year. Since then a growing number of publications have continued to validate the contribution of MammaPrint results for breast cancer prognosis. You can have a look at the list of scientific publications here.


 


 

Accreditation

ISO17025 Quality Standard

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Food and Drug Administration (FDA)

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Download K062694

Food and Drug Administration (FDA)

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Download K070675

College of American Pathologist (CAP) accreditation: 7194410

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CLIA certificate of Accreditation: 99D1030869

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European Medical Device Registration

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