The U.S. Food and Drug Administration (FDA) cleared for marketing MammaPrint, a molecular test that profiles genetic activity, and so can determine the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer.
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.
Prior to clearance, FDA requested evidence that the MammaPrint had been properly validated for its intended use. Agendia, the test manufacturer, 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).
FDA plans to publish a special controls guidance document within the next 60 days describing types of data that should support claims for genetic profiling for breast cancer prognosis.