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Agendia MammaPrint assay wins FDA clearance

Agendia has received fifth US Food and Drug Administration (FDA) approval for its MammaPrint, a breast cancer recurrence assay.

The approval includes two additional Agilent Microarray scanners and two Agilent Bioanalyzers, increasing aboratory capacity to handle the increasing number of MammaPrint, TargetPrint and BluePrint test requests.

The MammaPrint assay is a qualitative in vitro diagnostic test service.

The initiative allows the test to be performed in a central laboratories like CLIA and CAP accredited facilities in the US market.