Tute Genomics Stops Crowdfunding for DNA Sequencing Due to FDA Letter

Tute Genomics has suspended a crowdfunding campaign for genome testing after receiving an FDA letter about the company’s direct-to-consumer marketing.

The campaign was intended to extend both focused and comprehensive DNA sequencing services to consumers. “We’re proactively engaging with the FDA and working on the right path forward to make this happen,” the company said.

Tute Genomics had pursued fundraising after reviewing its DNA sequencing process and concluding that the process “does not involve what the FDA considers a ‘medical device,’ avoiding the need of a premarket review.” — José Vasquez