Additional oversight is warranted for all genetic tests.
The FDA should develop flexible mechanisms for review of new genetic tests that minimize both the time and cost of review. The FDA should give particular attention to the review of genetic tests for predictive purposes in diseases and conditions for which a safe and effective intervention has not been established. Initial exploratory data collection efforts among HHS agencies, which have been coordinated by the Centers for Disease Control and Prevention, have been of value and should continue. Protecting the confidentiality of the data is essential to the progress of data collection efforts. HHS agencies will require enhanced resources in order to carry out expanded oversight of genetic tests.