MammaPrint is the first and only breast cancer recurrence test cleared by the U.S. Food and Drug Administration (FDA). FDA clearance under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and analytical validation and reporting systems to ensure patient safety issues are addressed. Highly accurate, MammaPrint identifies patients with early metastasis risk - patients who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's CAP-accredited and CLIA compliant service laboratories. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.
Agendia is at the forefront of the personalized medicine revolution,
striving to bring more effective, individualized treatments within reach of
patients. Building on a cutting-edge genomics platform for tumor gene
expression profiling, the company's tests help physicians more accurately
tailor cancer treatments. Agendia markets four products, with several new
genomic tests under development. In addition, Agendia collaborates with
pharmaceutical companies to develop highly effective personalized drugs in
the area of oncology. Agendia is based in Huntington Beach, Calif
SOURCE Agendia B.V.
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