Breast Cancer Test Cleared by the FDA

The U.S. Food and Drug Administration announced today that it is authorizing the marketing of a test to determine the probability of recurring breast cancer. The decision is significant because the breast-cancer test is the first molecular test approved by the FDA that profiles genetic activity.

According to the FDA, “The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient’s body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens. The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients’ odds of the cancer spreading.”

MammaPrint was developed by Amsterdam’s Agendia laboratory and has been sold in the Netherlands since 2005.

“Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice,” said Dr. Andrew C. von Eschenbach, FDA commissioner. “MammaPrint results will provide patients and physicians with more information about the prospects for the outcome of the disease. This information will support treatment decisions.”

In support of its decision, the agency noted that “Agendia submitted data from a study using tumor samples and clinical data from 302 patients at five European centers. These studies confirmed that the test was useful in predicting time to distant metastasis in women who are under age 61 and in the two earliest stages of the disease (Stage I and Stage II) and who have tumor size equal to or less than five centimeters and no evidence that the cancer has spread to nearby lymph nodes (lymph node negative).”

The FDA says that nearly 180,000 women will be diagnosed with invasive breast cancer this year and that about 40,000 women will die from the disease.

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