FDA Clears Agendia's MammaPrint Dx; First IVDMIA to Get Green Light | GenomeWeb
NEW YORK (GenomeWeb News) — The US Food and Drug Administration yesterday said it has cleared Agendia’s MammaPrint diagnostic for breast cancer recurrence.
 
The test is the first in vitro diagnostic multivariate index assay device approved by the agency since it released a draft guidance describing such products last year.
 
As GenomeWeb News reported last fall, IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making, according to the draft guidance, which can be read here.

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