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MammaPrint(R) Breast Cancer Test Shown To Be Powerful Tool for Prognosis Prediction in Postmenopausal Breast Cancer Patients
Date:12/17/2007

Agendia to file for expanded FDA clearance for MammaPrint(R)

AMSTERDAM, Netherlands, Dec. 17 /PRNewswire/ -- Agendia BV, world leader in the rapidly evolving field of molecular diagnostics, announced today that its MammaPrint(R) breast cancer prognosis test was shown to be a valuable tool to assess risk of breast cancer recurrence also in postmenopausal breast cancer patients. Data recently presented at the AACR/NCI/ EORTC conference "Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications" in San Francisco showed that MammaPrint is a valuable tool to assess risk of breast cancer recurrence in older age breast cancer patients as well.

To date, MammaPrint has received two clearances from the Food and Drug Administration (FDA) for its test. The first clearance in February of this year cleared MammaPrint for safety and effectiveness under the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) Guidelines for use in breast cancer prognosis. In June, Agendia received a second clearance for the test in conjunction with RNARetain(R)*, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling. FDA clearance also ensures the validity of the RNA integrity chain from patient to result, which ensures that the whole test procedure is fit for daily clinical settings. With the new data, Agendia will seek additional clearance from the FDA for its MammaPrint breast cancer prognosis test to include patients over age 60.

In the underlying study, breast tumors from 100 patients with lymph node- negative, invasive breast cancer (median age 62 years, but also including elderly patients over age 75) who were diagnosed and treated at the Massachusetts General Hospital in Boston, USA between 1985 and 1997 were subjected to MammaPrint gene expression analysis. MammaPrint, having a digital readout, classified patients as being at eithe
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