FDA Halts 23andMe DNA Tests

Don’t try DNA tests at home, kids. The Food and Drug Administration asked genetic test maker 23andMe on Monday to stop selling personalized DNA kits. Regulators charge the DNA kits violate federal law because they claim to identify health risks for more than 250 diseases and health conditions. 23andMe previously managed to avoid any interference by claiming that it merely provided information about genetic history, not a medical service—but the service started providing disease-specific tests in its kit last year. In a letter posted online, the FDA suggested that it has gone to great lengths to work with 23andMe, but the agency “still does not have any assurance that the firm has analytically or clinically validated” its technology.