Agendia’s Genomic Risk Assay Cuts Need for Chemotherapy in Early Breast Cancer Patients by 46% in Phase 3 Trial

Agendia’s Genomic Risk Assay Cuts Need for Chemotherapy in Early Breast Cancer Patients by 46% in Phase 3 Trial
Agendia, Inc., announced initial positive results of a clinical trial investigating a genomic assay's ability to accurately predict the need for chemotherapy in early stage breast cancer patients thought at risk of disease reoccurrence. The Phase 3 trial, conducted by the company using its MammaPrint assay and in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and Breast International Group (BIG),  achieved a 46 percent overall reduction in adjuvant chemotherapy use by detecting a low probability of metastasis in high-risk patients. The analysis of the primary objective of the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) trial was presented at the 2016 American Association for Cancer Research Annual Meeting. MammaPrint, a 70-gene assay, is the first and only genomic assay approved by the U.S. Food and Drug Administration (510(k) clearance) for use in the risk assessment of women with early stage breast cancer. The MINDACT trial was designed to assess the clinical utility of the assay, and its potential use as a management and treatment-decision tool for breast cancer, in addition to the other factors relied upon by physicians, such as age, tumor size, tumor grade, lymph node involvement, and hormone receptor status. The Phase 3 randomized clinical trial (NCT00433589) enrolled 6,693 women who had undergone
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