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FDA Approves Breast Cancer Genetic Test

FDA has approved a diagnostic test that predicts the odds of whether or not breast cancer will return or worsen in a woman already diagnosed with the disease. MammaPrint, manufactured by Netherlands-based Agendia, is a gene-expression profiling test that analyzes breast tumor tissue and determines the chances that the cancer will recur. This could potentially help doctors decide what are the best options for treating their patients. Or could it?

Questions are already being raised about the performance of the test. Steven Gutman, MD, director of CDRH's Office of In Vitro Diagnostic Device Evaluation and Safety, notes that the test's computer analysis is less accurate when it predicts that the cancer runs a high risk of returning. Len Lichtenfeld, MD, the deputy chief medical officer of the American Cancer Society, says that the test might not be accurate enough to be used in determining treatment. According to the Washington Post, FDA is developing regulations for this kind of genetic testing. The agency plans on establishing a policy within the next two months that details the required data to support claims for genetic profiling for breast-cancer prognosis, says Gutman. FDA is holding a public hearing tomorrow to discuss its proposals for requiring approval for certain complex home brew tests.

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