Irresistible force meets immoveable object

Nature Biotechnology

32,

(2014)

doi:10.1038/nbt.2805

Published online: 09 January 2014

The US Food and Drug Administration (FDA) must clarify how it intends to enforce device regulation on direct-to-consumer (DTC) services that offer to interpret genome variation.

2013 was the year when the dream of DTC personal genome testing untrammeled by regulatory oversight finally was shattered. It was also the year when DTC genetics trailblazer 23andMe ran out of luck. It thumbed its nose at FDA and got a black eye. It gave the US regulator the cold shoulder for six months while launching a TV advertising campaign touting its “Personal Genetics Service” (PGS) for consumer health. And so the inevitable happened; in November, the company received an FDA warning letter demanding an immediate halt to testing “until such time as [the company] receives FDA marketing authorization for the device.” With the threat of injunctions and fines, 23andMe suspended its health advice services; it will still undertake genome analysis but only for genealogical purposes. Although the FDA action has sparked a firestorm of debate over the future of personal genetics companies, the practical question foremost in many minds is how will FDA enforce regulation across the entire risk spectrum of variants interpreted in a DTC genetics service?