23andMe DTC Genetic Health Risk Reports Approved by FDA

The FDA has granted marketing approval to personal genetics company, 23andMe, for their direct-to-consumer (DTC) Genetic Health Risk (GHR) tests. The tests – which provide individuals with their genetic risk of developing 10 different diseases and conditions – are the first FDA-approved tests of their kind on the market.

According to the FDA, the GHR tests may help individuals make informed decisions about lifestyle factors, as well as drive meaningful conversations with their doctors. However, the real challenge comes in ensuring consumers understand the implications of being genetically predisposed to a disease, and that it doesn’t guarantee that a person will develop the condition in the future.

“Consumers can now have direct access to certain genetic risk information,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”

Conditions included in the GHR test, which analyzes over 500,000 genetic variants, are: Alzheimer’s disease, celiac disease, Parkinson’s disease and hereditary thrombophilia, and others. The reports are set to launch this month, and 23andMe says they plan on releasing further tests in the future.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” said Anne Wojcicki, 23andMe CEO and co-founder. “The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics.”

The GHR reports were approved through the FDA’s de novo classification pathway for first-of-a-kind medical devices. 23andMe has also received pre-market review exemptions from the FDA for any additional GHR tests they develop.

The approval was based upon the availability of scientific literature providing demonstrated links between the genetic variants tested and the 10 health conditions included in the GHR panel. The GHR tests themselves were shown to consistently provide accurate results on genetic disease risk from patient saliva samples.

The FDA does warn that like all diagnostic tests, the 23andMe GHR tests can return false-positive or false-negative results. Because of this, the regulator says that the GHR tests should not be used for disease diagnosis, nor should they be considered sufficient evidence to start treatment for a specific disease or condition.