FDA Clears Breast Cancer Specific Molecular Prognostic Test

Armen Hareyan's picture

The U.S. Food and Drug Administration (FDA) cleared for marketing a test that determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer. It is the first cleared molecular test that profiles genetic activity.

The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient's body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.

The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients' odds of the cancer spreading.


MammaPrint was developed by Agendia, a laboratory located in Amsterdam, Netherlands, where the product has been on the market since 2005.

"Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "MammaPrint results will provide patients and physicians with more information about the prospects for the outcome of the disease. This information will support treatment decisions.

Agendia compared the genetic profiles of a large number of women suffering from breast cancer and identified a set of 70 genes whose activity confers information about the likelihood of tumor recurrence. The MammaPrint test measures the level of activity of each of these genes in a sample of a woman's surgically removed breast cancer tumor, then uses a specific formula, known as an algorithm, to produce a score that determines whether the patient is deemed low risk or high risk for spread of the cancer to another site. The result may help a doctor in planning appropriate follow-up for a patient when used with other clinical information and laboratory tests.

The MammaPrint is the first cleared in vitro diagnostic multivariate index assay (IVDMIA) device. Several months ago, FDA issued a draft guidance document concerning the need for these complex molecular tests to meet pre-market review and post-market device requirements even when the tests are developed and used by a single laboratory. Although FDA regulates diagnostic tests sold to laboratories, hospitals and physicians, it uses discretion when regulating tests developed and performed by single laboratories.

On February 8, FDA