The MammaPrint® test was developed by Agendia. The test is designed to provide breast cancer patients with additional information about the likelihood that their cancer will return (recur).
What the test does. The MammaPrint® test requires a sample of the tumor. The tumor tissue is examined to determine the activity levels (transcription levels) for 70 different genes that have previously been shown to be involved in the spread (metastasis) of breast cancer. Based on which genes are active, and their levels of activity, the test is able to predict how likely any particular cancer is to return after surgery.
Which patients should consider MammaPrint®? The test has been shown to be useful for women with early stage invasive breast cancer (stage 1 or 2), whose cancer has not been shown to have spread to their lymph nodes (node negative). The presence or absence of the estrogen receptor (ER) does not influence the test.
What are the results of the MammaPrint® test? The test has only two possible outcomes. Results are classified as either 'low risk' or 'high risk'. For patients whose tumors measure as 'high risk', the tumor has a 29% chance of returning within 10 years if the patient does not take ANY additional treatment.
For patients whose tumors measure as 'low risk', the tumor has a 10% chance of returning within 10 years if the patient does not take ANY additional treatment.
The results are used in combination with all of the other available information about the patient to help decide what additional treatments the patient should take (i.e. hormonal treatments and/or chemotherapy).(1)(2)(3)
The MammaPrint test was the first genetic test of its kind to be approved by the US Food and Drug Administration (FDA).(4)