The MammaPrint test (microarray) is an FDA cleared test and is CE marked (IVDR-certified). It may be appropriate if:

• • FDA*: your breast cancer is early-stage (I and II), lymph node-negative or have 1-3 positive lymph nodes, and the tumor size is less than or equal to 5cm.
  • IVDR-CE mark: you are a female breast cancer patient with Stage I or Stage II disease who is lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MammaPrint® FFPE** result is indicated for use by physicians and should be interpreted along with other clinico-pathological factors.