MammaPrint 70-gene profile quantifies the likelihood of recurrence for early breast cancer

BACKGROUND: Over the past few years, a variety of multigene expression profiles have been developed to improve prognostication for early stage breast cancer and reduce overtreatment with chemotherapy. MammaPrint is the only test cleared by the US Food and Drug Administration for the prognostication of early breast cancer. The MammaPrint assay examines the expression of 70 genes in the primary tumor to stratify patients diagnosed with early stage breast cancer into good and poor prognosis groups. OBJECTIVE: This evaluation reviews the development of the 70-gene profile, including validation studies involving patients with node-negative and 1 - 3 node-positive disease, the conversion of the 70-gene profile to a high-throughput diagnostic test, and the continuing prospective MINDACT clinical trial. CONCLUSION: The MammaPrint assay should help to determine which women with early breast cancer could be spared adjuvant chemotherapy.