TUESDAY, Feb. 6 (HealthDay News) -- The U.S. Food and Drug Administration has approved a test that can detect a genetic signature in breast tumor samples that is associated with a greater risk of metastasis over a five- to 10-year period. MammaPrint, a microarray that detects the activity of 70 different genes, is the first in vitro diagnostic multivariate index assay (IVDMIA) device approved for marketing in the United States.
"Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, in a statement. "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."
An Amsterdam-based laboratory, Agendia, developed the test, which has been available in the Netherlands since 2005. Agendia has validated the test in women under age 61 who had Stage I or Stage II tumors no larger than 5 centimeters that had not yet metastasized. For approval, the company submitted data on 302 patients treated at five European centers.
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