Agendia's MammaPrint Is First IVDMIA to Win FDA OK; Will New Imprimatur Be Advantageous? | GenomeWeb
The US Food and Drug Administration this week cleared Agendia’s MammaPrint molecular diagnostic, making it the first in vitro diagnostic multivariate index assay to win a green light since the agency issued a draft guidance describing such products last year.
MammaPrint was previously available as a homebrew test from April 2005 until August 2005. The test has been available in Europe since 2004.

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