Regulating laboratory-developed tests.

You argue in your March editorial1 that the US Food and Drug Administration (FDA; Rockville, Maryland) should keep out of the regulation of genetic tests. The editorial is framed as a reaction to a petition Genentech (South San Francisco, California, USA) filed with FDA last December proposing that the agency regulate genetic tests on the basis of their complexity and risk, not on whether they're produced in-house (with little or no oversight) or as a commercial kit (which means they will have gone through all the available regulatory hoops to ensure public safety).