FDA Authorizes Marketing of 23andMe Direct to Consumer Genetic Health Risk Tests

The FDA has authorized the marketing of the first direct to consumer (DTC) genetic health risk reports, offered by 23andMe, a California corporation offering genetic testing services. These are their Personal Genome Service Genetic Health Risk (GHR) products. The company describes the tests:

A genetic health risk report offers customers the opportunity to see whether they have genetic variants that increase their chances of developing certain health conditions. Not everyone with a risk variant will develop the health condition. And for most of these conditions, not having a genetic variant does not eliminate the risk of the health condition.

The FDA described the approval of the tests:

The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.

The FDA reviewed data for the 23andMe GHR tests through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the tests’ accuracy, reliability and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar GHR tests.

In addition, the FDA intends to exempt additional 23andMe GHR tests from the FDA’s premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification. A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible and in the least burdensome way, after a one-time FDA review.

The FDA requires the results of all DTC tests used for medical purposes be communicated in a way that consumers can understand and use. A user study showed that the 23andMe GHR tests’ instructions and reports were easy to follow and understand. The study indicated that people using the tests understood more than 90 percent of the information presented in the reports.

The Federal Trade Commission has published consumer protection materials relevant to purchasing DTC testing products. 23andMe has had a number of regulatory encounters with the FDA over the last several years (see earlier post here), and is slowly achieving more official recognition of their health-related testing products. However, the DTC dimension of these products is still a source of professional concern and caution among genetics professionals (see here). Market reception for these products will indicate whether a cohort of consumers develops which can be studied for their use and satisfaction with these testing services.