FDA letter prompts Tute to cancel genome sequencing crowdfunding campaign

FDA sign

Tute Genomics has suspended its direct-to-consumer DNA sequencing crowdfunding campaign after receiving a letter from the FDA. The action means Tute won’t provide exome and full genome sequencing services to the more than 70 people who requested them through the crowdfunding campaign on Kickstarter.

When Tute began the campaign on September 13rd, it gave the public the opportunity to source a range of sequencing services. At that time, early-bird promotions allowed people to sign up to get their exome sequenced for $399 or whole genome analyzed for $999, offers that resulted in Tute raising almost half of its $100,000 target in the first 24 hours of the campaign.

The quick start to the campaign showed Tute had attracted the attention of the public. Now, it has become clear Tute was similarly fast to attract the attention of the FDA, which fired off a letter on the day the campaign was celebrating passing the $50,000 mark.

“On September 15th, I received a letter from the FDA concerning our approach of marketing genome sequencing and analysis directly to consumers. After much deliberation, and active discussion with the FDA, it is with great sadness that we are postponing this campaign,” Tute CEO Reid Robison wrote in an update to backers of the Kickstarter campaign.

The update is light on details of the type of letter sent by the FDA or specifics of the regulator’s concerns with the campaign. But, after spending two weeks trying to find a way forward, Tute has pulled the plug on the campaign well before it was due to end on October 26. At the time Tute cancelled the campaign, it had received just shy of $75,000 in pledges for genome or exome sequencing and smaller rewards such as software access and t-shirts.

Robinson is aiming to fulfill these requests down the line--the email signoff is “we’ll be back”--but the experience of 23andMe suggests it could be sometime before Tute works out its differences with FDA. It took 23andMe two years to get the health-focused aspects of its service back online after the FDA hit it with a warning letter.

Tute thought it had avoided a similar fate by “[taking] care to ensure that our process does not involve what the FDA considers a 'medical device', avoiding the need of a premarket review.”

With the FDA seemingly disagreeing about the regulatory status of the service, people who want to learn about their DNA are limited to the SNP services offered by 23andMe and others, and the physician-requested sequencing provided by Veritas Genomics.