MammaPrint® FFPE is a qualitative, non-automated in vitro diagnostic test, performed in a Agendia’s Diagnostic Service 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.MammaPrint provides prognostic information regarding patient’s risk of distant metastasis and prediction of the magnitude of systemic therapy benefit to guide treatment decisions in patients with breast cancer.The MammaPrint genes measure the characteristics of the multiple step development of breast cancer cells to survive, proliferate, disseminate and metastasize as covered within the hallmarks of cancer.The test is performed for female breast cancer patients, Stage I or Stage II disease who are 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.
A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).
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