TRENDS & PERSPECTIVES
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The MammaPrint by Agendia.
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MammaPrint is a DNA microarray-based test that measures the expression levels of 70 genes from a breast cancer tumor sample. Using an algorithm, the test provides information about the likelihood of tumor recurrence and the risk for spread of the cancer to another site.
As the first in vitro diagnostic multivariate index assay (IVDMIA) to be cleared by FDA, the MammaPrint signals movement in the direction of personalized medicine. “This, in combination with other types of molecular tests, represents a first step in what we hope to be an increasing important new set of tools for the advancement of personalized medicine,” said Steven I. Gutman, MD, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety.
“Molecular diagnostics is changing the way people are thinking about managing patients and I am very heartened by the fact that FDA has approved a product in this space,” said Amit Kumar, president and chief executive officer at CombiMatrix Corp. (Mukilteo, WA). “There are a lot of steps toward personalized medicine; it’s hard to characterize anything as a big step. There will be lots of moderate steps that will eventually revolutionize the way medicine is practiced.”
Approval of the MammaPrint is, however, not without caveats. “This test is cleared as a prognostic test. This test does not provide information on what the best treatment would be,” said Gutman. “Further studies and innovations with these types of tests could, in the future, help determine improved methods for treating patients.”
Len Lichtenfeld, MD, deputy chief medical officer at the American Cancer Society, describes the limitations of the test: “FDA was very specific in what circumstances the test could be considered. They defined women eligible for this test as under age 61 with a breast cancer less than 5 centimeters in diameter and no evidence of cancer in the lymph nodes. Also, the test must be done with fresh tissue sent to Agendia’s laboratory. If there is no fresh tissue available, then this particular test cannot be done. Another test, called Oncotype DX (Genomic Health; Redwood City, CA), uses paraffin embedded samples, which is the way the pathologist prepares slides for the microscope.”
Lichtenfeld goes on to describe the real-world impact of molecular tests that profile genetic activity in breast cancer patients, “To get to the day when tests of this type will in fact be relied on by patients, families, and doctors, we will need more research and more clinical trials. The FDA announcement notwithstanding, we are not there yet.”
The MammaPrint has been available in Europe since 2004. In April 2005, FDA responded to information on Agendia’s Web site indicating intentions to distribute in the United States with an invitation for Agendia to seek regulation of MammaPrint. Agendia submitted the test for review in September 2006 and gained approval in February 2007. Agendia is currently exploring ways to make MammaPrint available in the United States. No time frame for U.S. distribution has been set.
“Prior to submitting its device for clearance, Agendia and FDA worked interactively through a protocol review process,” said Gutman. “This up-front communication enabled a smoother and more efficient clearance process.”
A summary of the supporting data for the clearance of the MammaPrint along with a control guidance document describing types of information needed for other manufacturers to offer similar FDA-cleared tests will be posted on the FDA Web site in the near future. Selected molecular diagnostic tests that have been cleared recently include the AmpliChip CYP450 by Roche Diagnostics (Indianapolis), the UGT1A1 assay by Third Wave Technology (Madison, WI), and several assays for diagnosis of cystic fibrosis and other inherited genetic variations.
