FDA to regulate genetic tests as “devices”

June 14, 2010

The US Food and Drug Administration (FDA) has dealt the controversial world of consumer genomics a major blow, by issuing five major companies with letters stating their intention to formally regulate the industry. The letters – sent to 23andme, deCODEme, Navigenics, Knome, and the sequencing company Illumina – equate a personal genome service with a medical device, which falls under section 201(h) of the Federal Food, Drug, and Cosmetic Act. This action follows hot on the heels of the FDA’s recent intervention in relation to relative newcomer Pathway Genomics, which recently withdrew plans to sell its genome profile over-the-counter in the US. (PHG Foundation)