FDA Clears Breast Cancer Specific Molecular Prognostic Test
MedSun: Newsletter #12, February 2007
FDA has cleared for marketing a test that determines the likelihood of breast cancer returning within 5 to 10 years after a woman's initial cancer. It is the first cleared molecular test that profiles genetic activity.
The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize. 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 Agendia, a laboratory located in Amsterdam, The Netherlands, where the product has been on the market since 2005.
"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. "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.”
For more information, go to the FDA Web site at