Microarray Test for Breast Cancer Metastases

A new microarray personalized diagnostic test was shown to outperform all standard diagnostic criteria now in use for predicting future development of distant metastases in breast cancer patients and overall survival in a validation study. These results were presented at the San Antonio Breast Cancer Conference in Texas in December 2004.

Researchers at the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AVL) initially identified and validated the 70-gene signature that predicts the development of distant metastases in lymph node-negative primary breast cancer patients. This gene signature has been developed into the diagnostic microarray, called MammaPrint. The Microarray is being marketed by Agendia BV (Amsterdam, The Netherlands), a company formed as a spinoff of NKI/AVL in 2003.

The validation study, involving centers in France, Sweden, the United Kingdom, and the United States, was based on the frozen archival tumor material of 291 node-negative breast cancer patients under 60 years of age who were diagnosed through 1998, and who had received only surgery or radiotherapy. A larger international randomized clinical trial will examine the utility of the signature in clinical practice.

The test could be useful in adding new information in cases where conventional diagnostic tests produce ambiguous results, according to Prof. Dr. Ren Bernards, chief scientific officer of Agendia. "In addition, MammaPrint is also very useful for patients that are considered to be at low risk for metastatic disease by the classical diagnostic tests.” Such patients do not receive chemotherapy today, but a significant number of them turn out to be at high risk by the MammaPrint test and should consider chemotherapy to reduce the risk of metastatic disease, advised Prof. Bernards.



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