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.
