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FDA approved test that determines risk of breast cancer recurrence
The test uses molecular technology to predict potential recurrence within five to 10 years.
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The FDA has cleared for marketing a molecular test that profiles genetic activity and determines the likelihood of a recurrence of breast cancer within five to 10 years after the initial cancer.
Cancer recurrence is dependent partly on the activation and suppression of specific genes in the tumor. The MammaPrint test (Agendia) measures the gene activity, which helps physicians determine the odds of their patient’s cancer spreading. The test uses microarray analysis to study behavior patterns of genes in women with breast cancer.
“Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice,” Andrew C. von Eschenbach, MD, commissioner of the FDA, said in a press release.
Researchers at Agendia compared genetic profiles of women with breast cancer, and identified a set of genes that confer information about possible tumor recurrence. The test measures the activity of these genes in samples of surgically removed breast tumors, and then uses an algorithm to issue a score that indicates a high or low risk of breast cancer metastasis. This information could help physicians plan follow-up care.
“Tests that predict the prognosis of an individual will become increasingly important in the years ahead,” William Hait, MD, PhD, Breast Cancer section editor for Hem/Onc Today, said in an interview. “This will certainly be the case when additional tests that predict response to different types of treatment become more robust and can be coupled with a prognostic indicator.”
FDA clearance
The MammaPrint is the first approved in vitro diagnostic multivariate index assay device. Recently, the FDA issued a draft guidance document stating that complex molecular tests need to meet pre-market review and post-market device requirements, even if the tests were developed and used by a single laboratory.
“There have been rapid advances in microarrays and other pioneering diagnostics, and a corresponding increase in the use and impact of these complex tests,” Steven Gutman, MD, director of the FDA’s Office of In Vitro Diagnostic Device Evaluation, said in a press release. “This has prompted the FDA to take a closer look at the potential risks as well as the benefits associated with such tests when they are developed and used in laboratories.”
Before approval, the FDA received evidence that the test was validated for its intended use. A study of tumor samples and clinical data from 302 patients in Europe confirmed that the test could predict time to metastasis in women younger than 61 with stage I or II breast cancer, tumor size 5 cm or less and no evidence of metastasis to lymph nodes.
Hait said, however, that the test has not been shown to predict the best choice of treatment, nor is it a tumor marker of early recurrence.
“Until these data are available, these tests will have to be used with caution, and only when knowing the result will change a physician’s recommendation for therapy,” Hait said.
The FDA plans to release a controls guidance document describing data that support claims for genetic profiling for breast cancer prognosis. – by Emily Shafer