In 2013, 23andMe founder Ann Wojcicki received a warning letter from the FDA asking her popular company to halt services that told customers they were at genetic risk of disease. "You are marketing the 23andMe Saliva Collection Kit and Personal Genome Service without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act," that document read. "23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."

That time is now, as the FDA announced today, making 23andMe the first direct-to-consumer test — no doctor required — that provides information on genetic predisposition to medical diseases or conditions. While 23andMe worked to gain FDA approval, it marketed itself as an ancestry testing service. But now the company, named for the 23 pairs of chromosomes in the human body and funded by Google/Alphabet, will notify users who spit into their test kits and send them back if they are genetically predisposed to Parkinson's disease, late-onset Alzheimer's disease, celiac disease, and 7 other conditions or diseases.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” 23andMe CEO and co-founder Anne Wojcicki said in a statement shared with the Business Times. “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.”

23andMe began offering tests for a genetic condition called Bloom Syndrome in 2015 with FDA approval, a step toward the approval the company's device enjoys today. Going forward, the Verge writes, the FDA won't need to perform additional reviews for every new genetic health risk report 23andMe would like to add to its service. That decision also paves the way for more genetic testing kits along the lines of those created by 23andMe: They too will likely proceed through a one-time test and iterate without need of more approval

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

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