Agendia's Breast Cancer Test MammaPrint(R) Standard of Care at Netherlands Cancer Institute - AVL
Posted on: Wednesday, 4 February 2009, 01:00 CST
"We are very pleased that MammaPrint will become available for all
eligible breast cancer patients at the NKI-AVL hospital," said
About MammaPrint(R)
MammaPrint is the first 'in vitro diagnostic multivariate index assay' (IVDMIA) cleared by the U.S. Food and Drug Administration (FDA). FDA clearance requires clinical and analytical validation and reporting systems to ensure patient safety issues are addressed. Highly accurate, MammaPrint identifies patients with early metastasis - those 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 result provides a doctor with a clear rationale to assess the benefit of adjuvant chemotherapy in addition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's CLIA-certified service laboratory. All other breast cancer recurrence assays currently marketed have not been subject to the rigorous FDA clearance process.
About Agendia
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 aim to help physicians more
accurately tailor cancer treatments. The company 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
SOURCE Agendia B.V.
Source: PR Newswire
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