New England Journal of Medicine Publishes MINDACT Trial Results Proving the Clinical Utility of MammaPrint® in Assisting Physicians to Identify Early-Stage Breast Cancer Patients who can Safely Forgo Chemotherapy

  • 46% of patients identified as high risk for recurrence according to clinical-pathological factors as described in the publication, and who therefore would be usual candidates for adjuvant chemotherapy, were reclassified as Low Risk by MammaPrint® and MINDACT shows could possibly forgo chemotherapy.[1]
  • Other tests like the Oncotype DX® Breast Cancer Assay (21-gene assay) can result in 39%[2] to 67%[3] of patients having indeterminate recurrence scores (RS 11-30)[4], which do not provide physicians with clear treatment options for their patients. MammaPrint provides definitive Low Risk and High Risk results, no intermediate results.
  • MammaPrint is the first and only genomic assay with FDA 510(k) clearance for use in risk assessment for women of all ages with early stage breast cancer.  FDA 510(k) clearance of the laboratory developed test (LDT) MammaPrint assures the safety of a product through analytical validation that other LDTs without such clearance (i.e. Oncotype DX) are not required to provide.

For more information on MammaPrint and the Agendia Suite of Products and if you are eligible for this test, please visit the FAQ link below and consult your physician.

[1] Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.

[2] Carlson JJ, Roth JA. The impact of the Oncotype DX breast cancer assay in clinical practice: a systematic review and meta-analysis. Breast Cancer Res Treat. 2014 Jul; 146(1): 233.

[3] Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015; 373: 2005-14.

[4] Oncotype clinical recommendations as recurrence score (RS) 0-17 = low risk (49%), RS 18-30 = intermediate risk (39%), and RS >30 as high risk (12% (Carlson JJ 2014). However, the recently published TAILORx study4 considers RS 0-10 = low risk (16%), RS 18-25=intermediate risk (67%), and RS >25 as high risk (17%) (Sparano JA 2015)

For more information visit the following pages:

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