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Agendia Publishes Direct Evidence That MammaPrint Predicts Benefit of Chemotherapy in Breast Cancer
Date:2/18/2009

e (pCR) rate and the results of the MammaPrint(R) test. The achievement of pCR is a valuable indicator for long-term response in this clinical setting. A consecutive series of 167 patients who received neoadjuvant chemotherapy for stage II or III breast cancer was analyzed to assess MammaPrint's predictive power. 20 percent of the 144 patients in the high risk group achieved a pCR, whereas none of the patients in the low risk group achieved a pCR. After a median follow-up of 25 months, 17 relapses were seen in the high risk group and none in the low risk group. These findings demonstrate that tumors with a high risk MammaPrint(R) signature are sensitive to chemotherapy.

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 risk - 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 chemotherapy in addition to other clinical information and pathology tests.

All MammaPrint tests are conducted in Agendia's CLIA-certified service laboratory. Breast cancer recurrence assays currently marketed by other manufacturers 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 t
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SOURCE Agendia B.V.
Copyright©2009 PR Newswire.
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