Microarray Analyzes Breast Tumors

Called MammaPrint, the test can more accurately distinguish between lymph-node-negative breast cancer patients who would benefit from additional therapy and those patients who would not. Thus, the test results will be useful to oncologists, who will be able to offer more-effective therapy to those patients whose cancer will spread. MammaPrint was developed by Agendia BV (Amsterdam, The Netherlands) and is now available from The Molecular Profiling Institute, Inc. (Phoenix, AZ, USA), the sole provider in the United States.

MammaPrint analyzes 70 genes in a woman's breast tumor that predict the 10-year survival of the patient at a significance level more than three times greater than existing methods and with an accuracy level of 96.7%. MammaPrint also identifies those untreated individuals who have a poor tumor signature and a high risk for metastasis if untreated.

The cost of the test in the United States is U.S.$3,200. This covers collection and preservation of the genetic material in fresh tissue and substantial genetic microarray testing and analysis of the 70 relevant genes. The U.S. Food and Drug Administration (FDA) has determined that its clearance or approval of the test is not necessary.

"Existing methods can't distinguish the patients with a high risk for recurrence from those with low risk with comparable accuracy,” said Dr. David Alberts, director of the Arizona Cancer Center. Currently, one of the most important prognostic indicators for the cancer recurring is the size of the tumor. However, a significant number of tumors less than 1cm in diameter are actually high risk tumors.





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Molecular Profiling Inst.