HUNTINGTON BEACH, California and AMSTERDAM, February 4 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced that its signature breast cancer test MammaPrint(R) will be offered as standard of care for all eligible early stage breast cancer patients at the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL). The NKI-AVL believes MammaPrint provides better guidance for decisions regarding adjuvant therapy. As one of the participating centers in the MINDACT trial NKI-AVL is already offering MammaPrint to patients and will continue to do so. In future, however, NKI-AVL will also make MammaPrint available to patients who fall outside MINDACT's inclusion criteria.
We are very pleased that MammaPrint will become available for all eligible breast cancer patients at the NKI-AVL hospital, said Bernhard Sixt, Ph.D., president and chief executive officer of Agendia. The NKI-AVL is a worldwide acknowledged center of excellence and a leading institution in advancing cancer treatment and care. Agreements with other hospitals and the recent inclusion of MammaPrint in the updated 2008 clinical practice guidelines of CBO, the Dutch Institute for Healthcare Improvement, ensure that an ever increasing number of breast cancer patients can rely on MammaPrint.
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.
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 Huntington Beach, California, and in Amsterdam, The Netherlands. For more information please visit http://www.agendia.com.
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