The American Medical Association (AMA) has granted a Category I multianalyte assay with algorithmic analysis (MAAA) current procedural terminology (CPT) code for the MammaPrint 70-gene breast cancer recurrence assay from Agendia Inc, Irvine, Calif.

“Approval of the Category I CPT code for MammaPrint is an important reimbursement milestone for Agendia,” says Mark Straley, chief executive officer at Agendia. “Following the recent publication of the Mindact study in the New England Journal of Medicine, this announcement underscores the importance of having Level 1A evidence supporting the clinical utility of the MammaPrint assay. Our new Category I MAAA CPT code, along with our Level 1A evidence, will facilitate reimbursement negotiations with payors and professional associations to ensure further access to this important test for women diagnosed with early-stage breast cancer.”1

The company also announced the launch of a new patient-focused platform, “Know If You Need Chemo, Know If You Don’t!” The campaign’s goal is to increase awareness of the MammaPrint  test and to provide patients and their physicians more clarity in their treatment decision. As part of the campaign, Agendia launched a new patient-centered website (, where patients can find more information about the MammaPrint test and hear from others who have had similar diagnoses.

“The decision to utilize chemotherapy for breast cancer patients is one of the most challenging decisions that we face as physicians,” says William Audeh, MD, chief medical officer at Agendia. “We believe that it is important for patients to know what their options are and to work with their physician to make their treatment decision with confidence. For patients with early-stage breast cancer, MammaPrint is the only assay with the highest level of evidence (Level 1A), to help physicians make the critical decision as to whether chemotherapy should or should not be part of the treatment plan. As proven in the definitive Mindact trial, 46% of women with breast cancer and high-risk clinical features were able to safely avoid chemotherapy based on their MammaPrint results.”

MammaPrint is a diagnostic test that helps predict clinical outcomes in women with early-stage breast cancer, identifying patients who in the presence of a high-risk clinical assessment are unlikely to benefit from chemotherapy. It is the only FDA-cleared breast cancer recurrence assay designed for woman of all ages, according to the company.

For more information, visit Agendia.


  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(8):717–729; doi: 10.1056/nejmoa1602253.