IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces the peer-reviewed publication of the primary outcome results of the Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) clinical trial in the prestigious New England Journal of Medicine (NEJM). [i, iii, iv] The publication demonstrates that 46% of breast cancer patients considered for chemotherapy, whose tumors are classified MammaPrint Low Risk, have excellent survival without chemotherapy, and can thus be candidates to avoid this toxic therapy. [i, pg. 717]

“Now indeed, we have the only genomic assay with Level 1A evidence to help physicians more accurately predict risk of distant metastasis in patients with early-stage breast cancer.”
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MINDACT is a collaboration between Agendia, the European Organization for Research and Treatment of Cancer (EORTC) and the Breast International Group (BIG). A unique phase III prospective, randomized, controlled study of 6,693 patients across 112 European cancer centers, MINDACT provides the highest level of clinical evidence (Level 1A) and confirms the clinical utility of using Agendia’s MammaPrint 70-gene breast cancer recurrence assay to help predict clinical outcome in women with early-stage breast cancer.

“When we developed MammaPrint, we knew we wanted to achieve the same level of evidence required for a typical pharmaceutical drug. That is why we are one of only a few diagnostic tests with FDA clearance and why we rigorously evaluated MammaPrint in the context of clinical-pathological factors in the randomized MINDACT trial,” said Prof. Laura van ’t Veer, Chief Research Officer at Agendia, and Leader, Breast Oncology Program, and Director, Applied Genomics at UCSF Helen Diller Family Comprehensive Cancer Center. “Now indeed, we have the only genomic assay with Level 1A evidence to help physicians more accurately predict risk of distant metastasis in patients with early-stage breast cancer.”

MINDACT is the first prospective translational clinical study of this magnitude in early-stage breast cancer to report the results of its primary objective and publish them in a peer-reviewed journal. At 5 years, patients who did not receive adjuvant chemotherapy but were classified as being at high risk for breast cancer recurrence based on clinical-pathological factors and as being at Low Risk based on MammaPrint, had similar rates of disease free survival. [i, pg. 717]

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