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What is MammaPrint?
Benefit from MammaPrint
MammaPrint test Results Mean
FDA cleared MammaPrint

Why is an FDA cleared test important to you?

Since you and your doctor are making vital treatment decisions based on your test results, the importance of regulatory review and clearance cannot be overstated. MammaPrint's clearance
by the United States Food and Drug Administration (FDA) as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) confers
confidence in its safety and effectiveness. The FDA label indicates that as a diagnostic tool, MammaPrint has a 98.9% degree of accuracy in classifying patients as Low Risk or High Risk. MammaPrint is the only gene expression breast cancer test currently available in the United States that has met the FDA's strict IVDMIA clearance criteria.


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