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FDA Opens Genetic Floodgates with 23andMe Decision

Gene-testing companies will be able to directly tell consumers their risk for certain diseases.
April 6, 2017
23andMe can now sell spit-based genetic tests that estimate a person’s health risk for certain diseases directly to consumers.

Today, the U.S. Food and Drug Administration told gene-testing company 23andMe that it will be allowed to directly tell consumers whether their DNA puts them at higher risk for 10 different diseases, including late-onset Alzheimer’s disease and Parkinson’s.

The decision to allow these direct-to-consumer tests is a big vindication for 23andMe, which in 2013 was forced to cease marketing such results after the FDA said they could be inaccurate and risky to consumers, and that they required regulatory approval.

In softening its previous policy, the FDA said in a post on its website that it will begin allowing 23andMe to use consumers’ DNA to calculate their genetic risk of developing a range of diseases without seeking further regulatory clearance. Other companies could follow a similar process.

“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “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.”

The tests, the agency said, “should not be used for diagnosis or to inform treatment decisions,” but they may be used to “help make decisions about lifestyle choices or to inform discussions with a health-care professional.”

That’s pretty much exactly what 23andMe argued when it began offering its direct-to-consumer DNA test in 2007, sending buyers results that claimed to predict the risk of dozens of traits and conditions, from baldness to blindness.

Following the FDA’s clamp-down, 23andMe continued selling ancestry tests, and later it was allowed to offer carrier screening, which reveals genetic errors that don’t harm a person but could cause disease in a child if both parents have the mutation.

All the company’s tests are carried out on a saliva sample that is tested for more than 500,000 genetic variants after the customer mails it in. The company’s database contains over a million genetic profiles and has become a valuable resource for drug companies.

DNA data has now become an inexpensive commodity, and many companies would like to sell much more of it to consumers. One company, Veritas Genetics, has been offering to sequence a person’s complete genome for $1,000.

Getting those results still requires a doctor’s order, but Mirza Cifric, CEO of Veritas, says the FDA decision “reopens” the door to direct-to-consumer data. “We are going to drive the genome through that door,” he says.

He notes that a person’s genome contains information on “thousands of conditions, not just 10.”

According to a 23andMe spokesperson, the company, whose test is priced at $199, will start providing reports this month on the risk of five diseases: Alzheimer’s, Parkinson’s, hereditary thrombophilia, alpha-1 antitrypsin deficiency, and Gaucher’s.

Other conditions it could report on at a later date include Factor XI deficiency, celiac disease, hereditary hemochromatosis, and primary dystonia, a movement disorder involving involuntary muscle contractions.

The FDA’s latest decision was made in response to an August 2015 request by 23andMe under regulations for approving novel and low-to-moderate-risk medical devices. David Mittelman, a Houston-based geneticist and entrepreneur, says the move is a “net benefit” to consumers and a win for 23andMe, which is based in San Francisco and led by the entrepreneur Anne Wojcicki.  

“23andMe is like the AOL of genetics. AOL was so early for the market, and they kind of suffered because of that,” he says.

The problems with genetic risk results haven’t changed, however. The tricky part will be to make sure the test results don’t confuse consumers, cause panic, or induce them to undertake unnecessary medical procedures. The FDA says it requires companies to communicate the results in a way that consumers can understand and use.

People are able to understand about 90 percent of the information in 23andMe’s reports, according to a study by the company.

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