MammaPrint is a 70-gene microarray test which is used to assess the risk of metastases at an early stage of breast cancer with greater accuracy than is possible using conventional methods. MammaPrint reveals the activity (expression) of 70 specific genes in the tumor sample to indicate a ‘Low Risk’ or ‘High Risk’ profile (no intermediate). The risk of tumor recurrence is determined according to the degree of similarity between the tumor’s gene expression profile and reference profiles.
The test is performed on a tumor biopsy obtained from formalin-fixed paraffin-embedded (FFPE) tissue by the local pathologist following the test request on this website. The sample is then shipped overnight to Agendia’s ISO certified laboratory in the Netherlands, where the test is performed under an export permit obtained from the South African Department of Health. In general, results will be available within 10 working days after receiving a tumor biopsy.
To be eligible for a MammaPrint test, a breast cancer patient should fulfil the following
International criteria:
- Tumor size < 5.0 cm
- Up to 3 positive lymph nodes
- Stage 1 and Stage 2 invasive breast cancer
- Estrogen receptor (ER) + or –
- Tamoxifen independent
The test selection criteria for reimbursement by certain medical schemes in South Africa have been further redefined following a Health Technology Assessment (HTA) performed in 2009. A prescreen algorithm has been developed and incorporated into the Gknowmix Database for easy identification of breast cancer patients eligible for testing.
This innovation represents a unique development in the application of pathology-supported genetic testing aimed at the exclusion of inappropriate genetic testing and instant transformation of information pooled from different sources into an informative report for the treating surgeons and oncologists.
The BluePrint test for further tumour subtyping is offered together with the MammaPrint test.
Local experience of the MammaPrint service in routine clinical practice led to the following quotes from an opinion leader in breast cancer:
“Genomics is now an established and frequently used tool in medical research, and particularly in the oncology field. In breast cancer, genomics has led to a better understanding of the biology and to a molecular reclassification of the disease.”– Dr Rika Pienaar, GVI Oncology, Panorama Hospital, Cape Town, South Africa.
What are its benefits?
MammaPrint adds a new quality of data to existing prognostic tools as it gives better insight into the biology of the patient’s breast cancer tumor. As the test allows a better distinction to be drawn between high and low-risk patients, it is possible to reduce the number of breast cancer patients who are treated with chemotherapy. This means an improvement in the quality of life of breast cancer patients and substantial cost savings.
It helps clinicians to make the best-informed decisions based on a clear risk assessment for the recurrence of distant metastases in breast cancer patients.
