Op-Ed

An unused 23andMe kit, displayed with box open and containing specimen bag, cotton swab, and vile container.

The US Food and Drug Administration (FDA) has, for the first time, granted permission to a company to provide limited health information directly to consumers, bypassing the need for doctors or genetic counselors.

The company in question is 23andMe, a prominent direct-to-consumer (DTC) genetic testing service based in Mountain View, California. On 6 April 2017, the FDA provided 23andMe with approval to screen for ten health-related genetic conditions.[1]

Recent years have seen the cost of genetic sequencing fall at an astonishing rate,[2] which has helped enable the advancement of the DTC genetic testing industry. According to Anne Wojcicki, 23andMe’s co-founder and chief executive, “customers want their genetic data.”[3]

However, genetic testing is not a panacea for understanding individual health risks. Genetic variants do not inform you that you have a disease, but that you have a certain percentage likelihood of someday getting it. It remains unclear how useful this information really is.

In its news release, the FDA announced: “Consumers can now have direct access to certain genetic risk information, but it is important that people understand...