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). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. 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 an aid in estimating the prognosis of patients diagnosed with breast cancer. Decisions on treatment should be based on the independent medical judgment of the treating physician taking into consideration all available information concerning the patient’s condition, including other pathological tests, in accordance with the standard of care in a given community.

• The MammaPrint test (microarray) is an FDA cleared test and is CE marked (IVDR-certified).
  FDA Intended Use: the test is performed for breast cancer patients with Stage I or Stage II disease with tumor size ≤5.0cm and lymph node negative. The MammaPrint FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors. Coverage criteria for majority of health plans (in the US) include early-stage breast cancer, tumor size less than or equal to 5.0cm (≤5.0cm), up to 3 positive lymph nodes and independent of receptor status as validated in the 6,693 patient MINDACT trial.
• IVDR-CE mark Intended Use: 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.