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
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
"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
The MammaPrint is the first cleared in vitro diagnostic
multivariate index assay 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draft guidance document concerning the need for these complex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.