The high-profile and somewhat controversial personal-genetics company 23andMe announced in a press release and on its blog that it has delivered its first round of 510(k) documentation to FDA for its Personal Genome Service product. 23andMe CEO and cofounder Anne Wojcicki said, “23andMe is working proactively with the FDA to ensure the industry delivers high-quality information that consumers can trust.” 23andMe’s Personal Genome Service analyzes consumers' individual DNA and provides more than 200 health and trait reports, as well as genetic ancestry information.
“23andMe has pioneered the direct-to-consumer genetic testing industry, and we are committed to helping individuals understand their own genetic information through proven DNA analysis technologies and Web-based interactive tools,” Wojcicki said.
“23andMe has always valued the guidance of the FDA and, in fact, engaged the agency in conversations prior to launching the Personal Genome Service in 2007. Our ongoing conversations with the FDA in the last year, in particular, resulted in a focused approach that resulted in our ability to compile a comprehensive analysis of 23andMe’s direct-to-consumer testing for FDA consideration,” stated 23andMe VP corporate development and chief legal officer Ashley Gould.
The 23andMe platform is designed to be both fluid and transparent, the company said, and the filing with FDA is designed to accommodate this data-driven paradigm. The body of information provided by 23andMe grows over time, not only in adding more traits and health reports, but also in interpreting results based on the continued evolution of scientific literature, it said. 23andMe uses a CLIA-certified laboratory to process customer DNA samples.
“FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care,” explained Ms. Wojcicki. “As the knowledge around personalized medicine continues to grow, consumers should expect their healthcare providers to begin to incorporate genetic information into their treatments and preventative care.”