FDA Clears Test to Predict Breast Cancer Recurrence Risk
The Food and Drug Administration (FDA) has cleared for marketing a diagnostic test, for use in conjunction with other clinical information and laboratory tests, to assess the recurrence risk for women with early-stage, lymph node-negative breast cancer. The clearance is the first in a category of diagnostic device called an in vitro diagnostic multivariate index assay (IVDMIA).
The test - MammaPrint, developed by the Netherlands-based Agendia - predicts the likelihood of breast cancer returning within 5 to 10 years after a woman's initial cancer diagnosis, based on a microarray analysis of a panel of 70 genes in a sample from a patient's tumor.
The approval follows earlier studies - including a validation study involving more than 300 women published last September in JNCI - that showed gene signature scores on MammaPrint were predictive of time to distant metastases and overall survival.
NCI is sponsoring a trial called TAILORx that will use the results of a similar test, Oncotype DX, that measures the activity of a 21-gene panel in tumor samples from women with early-stage, estrogen receptor-positive, node-negative, invasive breast cancer to assign participants to their treatment regimen.
Unlike MammaPrint, explains Dr. Sheila Taube from the NCI Division of Cancer Treatment and Diagnosis, Oncotype DX has been tested on samples from clinical trials and shown to predict the likelihood of a patient benefiting from certain types of chemotherapy as well as of breast cancer recurrence.
Agendia applied for FDA clearance for the MammaPrint test even though it was not required to do so. However, FDA recently released a draft guidance document that suggested tests like MammaPrint and Oncotype DX may require formal FDA approval. Genomic Health, which developed Oncotype DX, currently offers the test under so-called home brew rules that don't require FDA clearance as long as samples are only being tested at a single, company-operated laboratory. The MammaPrint test also is currently conducted only at a single, company-operated laboratory.
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