|English: Validation chart for Agendia's MammaPrint Assay, part of the Symphony Breast Cancer Suite (Photo credit: Wikipedia)|
In patients with a low clinical risk but high genetic risk, the 5-year DMFS was 95% to 96% with or without chemotherapy.
As compared to standard clincopathological classification, MammaPrint re-stratified 20% of Clinical High Risk patients to Low risk. 97% of this Low Risk patient group which primarily chose to forgo chemotherapy, were disease free at 5 years.
The first ever prospective clinical study for a breast cancer recurrence assay, RASTER (MicroarRAy PrognoSTics in Breast CancER) was published in 2013.
"The MammaPrint FFPE (Formalin Fixed Paraffin Embedded) tissue test has been approved by the FDA."
It confirmed the utility of the MammaPrint (Agendia) 70-gene signature to identify those breast cancer patients that may safely forgo chemotherapy.