Product Disclaimer

BluePrint Disclaimer:

BluePrint® was developed and its performance characteristics determined by Agendia. It has not been cleared or approved by the US Food and Drug Administration (FDA). This test is used for clinical purposes. This test was performed at Agendia, Inc (05D1089250), which is certified under the Clinical Laboratory Improvement Amendment (CLIA) as qualified to perform high-complexity clinical laboratory testing. It has also been CE-marked for use in Europe.

MammaPrint Disclaimer:

MammaPrint® FFPE is a qualitative in vitro diagnostic test, performed in a central laboratory, using the gene expression profile obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The MammaPrint FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.