FDA Clears Agendia’s MammaPrint as Industry Frets Over Agency's IVDMIA Draft Guidance | GenomeWeb
The US Food and Drug Administration last week said it cleared Agendia’s MammaPrint breast cancer recurrence test for clinical use, marking the first time the agency has approved what it has dubbed an in vitro diagnostic multivariate index assay.
The Dutch company also became the first European diagnostics shop to successfully navigate the US regulatory agency with a microarray-based diagnostic.

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