FDA allows 23andMe to sell DTC genetic tests for 10 conditions

The FDA demanded that 23andMe stop selling its direct-to-consumer genetic health tests in 2013. Since then, the company and the agency have worked together to develop an improved product.

It’s been a long road for 23andMe, but not without reward. The FDA authorized the marketing of the company’s genetic health risk tests, the first tests OK’d by the agency that provide this information directly to consumers.

The company’s Personal Genome Service Genetic Health Risk tests detect a person’s genetic predisposition to 10 diseases or conditions, according to a statement. These include Parkinson’s disease, late-onset Alzheimer’s disease and Gaucher disease, among others.

While the information provided by the tests may be used to make lifestyle changes or in discussions with a healthcare provider, they alone cannot determine a person’s overall risk of developing a disease or condition, the FDA said in a statement.

“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., 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.” 

RELATED: The most influential people in biopharma 2016Anne Wojcicki

The latest market authorization marks a triumph for 23andMe. The FDA first ordered 23andMe to stop selling its genetic health test because patients could base medical decisions such as elective surgery on their results.

The agency said the genetic health tests should be regulated as a medical device. But CEO Anne Wojcicki saw them as a new product for people to better understand their bodies and so, deserved their own regulatory process. The company was allowed to market its genetic ancestry test while it worked on creating a new offering that would give patients a more complete idea of what their results meant.

Two years later, the company debuted an FDA-approved test for 36 autosomal recessive disorders.

23andMe’s newest tests were reviewed through the FDA’s de novo pathway. In the process, the agency is developing criteria, dubbed “special controls,” for assessing the accuracy, reliability and clinical relevance of tests like these, which help pave the way for other companies seeking to develop and market direct-to-consumer tests.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” Wojcicki said in a statement. “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.”