The FDA intends to more tightly regulate direct-to-consumer (DTC) genetic tests. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told Congress that the FDA will create a “draft oversight framework” for laboratory-developed tests (LDTs), a category that has up to now included DTC gene tests. LDTs are tests created and performed by one lab. The FDA asserts that DTC genetic tests often include a component, such as a DNA chip, not created by the lab and thus cannot be classified as LDTs. The FDA has said that regulation of DTC gene tests will be based on a test’s risk to consumers, or the extent to which its results could cause harm. In regulating such tests, the FDA will have to decide how to validate gene markers, how to determine the test’s accuracy and how to accommodate the additions to the test. For now, the FDA said it intends to notify companies whose tests it believes should be regulated as medical devices. The FDA has sent letters to 19 companies regarding the issue.

Source: Nature