23andMe launches new FDA-cleared service


23andMe is launching a new Personal Genome Service (PGS), touting as an entirely new experience that includes carrier status, wellness, trait and ancestry reports.

“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing,” said 23andMe co-founder and CEO Anne Wojcicki. “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.”

The service now delivers more tools, insights and better functionality. Priced at $199, it provides customers with a detailed, yet easy to understand genetic information service, validated by user testing. These include:

  • More than 60 health, ancestry, wellness, and personal trait reports
  • Reports on genetic research and new genetic discoveries
  • Personalized insights based on analysis of 650,000 genetic variations
  • Tools and features unique to 23andMe, such as segment level data for advanced genetic genealogy research and other patented features
  • The chance to find and connect with DNA relatives in a database of more than 1 million customers

Existing customers will be transitioned to the new experience, through that transition will be dependent on validation and local requirements.

In addition, PGS also provides customers with the opportunity to participate in research can accelerate the pace of discovery and improve the understanding of how genetics influences our lives. Those who consent to participate can easily contribute from anywhere by answering survey questions online and, in turn, receive insights along the way to help learn more about their genetics, see early findings from 23andMe research and learn how they compare to others. A new 23andMe Research mobile app will also be available on the Apple App Store.