FDA Asserts Authority Over Genetic Test Products Sold Directly to Consumers

In an effort to regulate direct-to-consumer genetic tests as medical devices, the Food and Drug Administration June 10 sent letters to five genetic test manufacturers, requesting premarket approval submissions for products already on the market.

The letters were sent to five companies: deCode Genetics, Illumina, 23andMe, Navigenics, and Knome. Alberto Gutierre, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, said in the letters the companies’ respective tests are considered medical devices, and so they must be subject to FDA’s device approval process and standards.

Navigenics, deCode Genetics, 23andMe, and Knome offer direct-to-consumer (DTC) genetic screening tests. ...