US FDA approves Agendia's MammaPrint

The US Food and Drug Administration has approved a test that determines the likelihood of breast cancer returning within five to 10 years after initial presentation. It is the first molecular test cleared in the USA that profiles genetic activity.

Developed by Amsterdam, Netherlands-based Agendia, the MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize. The test relies on microarray analysis, a 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 helping physicians understand their patients' odds of the cancer spreading, according to the FDA.