Almost two years after the FDA first told 23andMe to halt sales on its mail-order direct-to-consumer genetic testing service for disease risks, the company has relaunched a version of its new Personal Genome Service (PGS), which now meets FDA standards.
“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing,” 23andMe CEO Anne Wojcicki said in a statement. “We are a better company with a better product as a result of our work with the FDA. This is an incredibly dynamic time in genetics and we’re excited to be at the leading edge of bringing genetics directly to individuals as they begin to learn about their 23 pairs of chromosomes.”
23andMe’s offering, which first launched in 2007, sends users a saliva collection kit. After spitting in the tube provided and mailing it back to the company’s lab, 23andMe emails the user within about two months that their reports are ready and available to review in an online portal. The price of the original offering six years ago first started around $399, but over time was decreased to $99. The new offering that was just launched costs $199. The new Personal Genome Service provides users with more insights than the company offered before, according to the company.
One type of 23andMe report, the carrier status test, provides users with data on 36 inherited conditions, including cystic fibrosis and sickle cell anemia. Another report users will get helps them understand how their DNA relates to their caffeine consumption, lactose digestion, and muscle type.
During the two years that 23andMe was working with the FDA to develop this new offering, the company was still active both in the US and in other countries. Here’s a summary of what 23andMe has been up to since the FDA letter first came out.
November 22, 2013: The FDA instructed 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance.
“[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS [personal genome service],” Alberto Gutierrez, director of in vitro diagnostics and radiological health wrote in the letter, adding that FDA interactions with 23andMe had included “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications.” Keep reading>>