In August, the New England Journal of Medicine published an encouraging study on MammaPrint, a 70-gene diagnostic test that seeks to better predict breast cancer recurrence in women diagnosed with early-stage breast cancer. The genomic test, which was approved by the Food & Drug Administration (FDA) in 2007, can help physicians determine whether chemotherapy, a treatment plan that helps reduce cancer recurrence, is necessary.
In the randomized study, 6693 women with early-stage breast cancer were divided based on genomic risk and clinical risk of recurrence. 1550 were found to fall within the group of high clinical risk but low genomic risk, according to the MammaPrint test—a group that is often treated with chemotherapy. Yet the study found that, of this group, chemotherapy made a minimal impact in the 5-year rate of survival without distant metastasis (cancer recurrence). Chemotherapy recipients in this group had only a 1.5% higher 5-year survival rate. Patients in this group who did not receive chemotherapy had an encouraging 94.7% 5-year rate of survival without distant metastasis.
What is MammaPrint?
Though marketed in the U.S. since 2005, MammaPrint is not a common test ordered by physicians. MammaPrint is a genomic test, not to be confused with a genetic test, such as the popular BRCA test. Instead of analyzing mutations of genes and heredity, genomic tests (also called “assays”) evaluate tumor samples for activity of specific genes. The MammaPrint test, for instance, analyzes 70 specific genes within the tumor.
Who Is A Good Candidate For MammaPrint
The MammaPrint test does not work for all stages of breast cancer. It’s designed to analyze early-stage breast cancer patients (Stage I or II). In the U.S., the FDA has cleared MammaPrint to be used to test women of all ages with:
- Lymph-node negative breast cancer
- ER-negative or ER-positive breast cancer
- Tumors less than 5 cm
- Invasive carcinoma (infiltrating carcinoma)
MammaPrint Cost
According to an April 2016 article in Forbes, a MammaPrint test costs $3000-$4000. It is covered by Medicare and many private insurances. Agendia, the maker of the MammaPrint test, offers patient advocate services to help patients get the maximum coverage from their insurance providers. For those who are uninsured, underinsured or indigent, Agendia offers interest-free payment plans and payment assistance.
The MammaPrint test and associated clinical studies are still young, but we are eagerly awaiting the 10-year cancer recurrence rate of the women featured in the New England Journal of Medicine study. In the meantime, MammaPrint is a promising breast cancer screening tool that will help physicians reduce over-treatment of early-stage breast cancer cases.
