Guidelines issued by Cancer Care Ontario affirm the importance of the MammaPrint breast cancer risk of recurrence test for node-positive patients and node-negative patients with high clinical risk, says Agendia, Irvine, Calif.1
Endorsed by the American Society of Clinical Oncology (ASCO), the guidelines recommend the test as the only molecular diagnostic for patients who have breast cancer that has spread to their lymph nodes.The test is also recommended for select patients with node-negative breast cancer.

The guidelines issued by Cancer Care Ontario, the provincial agency responsible for improving cancer services for its residents, recommend MammaPrint for patients with estrogen receptor-positive or progesterone receptor-positive, HER2-negative breast cancer, and who have a high clinical risk for recurrence. Patients can either be negative for lymph node involvement, or positive with one to three lymph nodes positive for metastases. MammaPrint can help patients and their doctors determine whether adjuvant systemic chemotherapy should be part of their treatment regimen.

Based on microarray technology, Agendia’s MammaPrint uses a proprietary 70-gene expression profile to classify patients with breast cancer as having a ‘low’ or ‘high’ risk of recurrence over a period of 10 years. Oncologists and breast surgeons use the information provided by MammaPrint to help guide overall treatment strategy for patients diagnosed with early-stage breast cancer.


William Audeh, MD, Agendia.

“We know that cancer often does not remain localized to a specific part of the body. It can easily spread, especially through the lymph nodes, but that does not always mean that the patient is going to benefit from adjuvant systemic chemotherapy,” says William Audeh, MD, medical oncologist and Agendia’s chief medical officer.“Unfortunately, due to a lack of adherence to clinical guidelines, clinicians have used genomic assays that are not validated for patients with lymph node-positive breast cancer to help make decisions about the most beneficial treatment approach.

“We are pleased that the new guidelines now provide access to both centralized microarray and local next-generation sequencing platforms for Canadian patients and healthcare providers, and that the agency recognizes that MammaPrint is the only assay with enough evidence to be used in such a high-risk group of patients,” adds Audeh.

For more information visit Agendia.


  1. Eisen A, Fletcher GG, Gandhi S, et al. Optimal systemic therapy for early breast cancer in women: a clinical practice guideline. Curr Oncol. 2015;22(suppl 1):S67–S81; doi: 10.3747/co.22.2320.
  1. Henry NL, Somerfield MR, Abramson VG, et al. Role of patient and disease factors in adjuvant systemic therapy decisionmaking for early-stage operable breast cancer: update of the ASCO endorsement of the Cancer Care Ontario guideline. J Clin Oncol. 2019;37(22):1965–1977; doi: 10.1200/jco.19.00948.