25th October 2015

Biotech firm 23andMe to resume DNA health tests

Following two years of dialogue and review, the US Food and Drug Administration (FDA) has allowed 23andMe to begin offering personal DNA health tests again.

23andMe – a leading personal genetics company – this week announced the relaunch of their Personal Genome Service (PGS). Following two years of work with the FDA, extensive user comprehension testing and a complete redesign, 23andMe is launching an entirely new experience that includes carrier status, wellness, trait and ancestry reports.

In 2013, the FDA ordered 23andMe to discontinue marketing its service, because it lacked the required legal regulatory approval, resulting in concerns about the potential consequences of customers receiving inaccurate health results. 23andMe continued to sell a personal genome test without health-related results in the USA (but including ancestry reports) – until this week, when a completely revised service was announced with FDA approval.

“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing. We are a better company with a better product as a result of our work with the FDA,” 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, more insights and better functionality. For $199, customers receive a detailed, but easy to understand genetic information service validated by user testing:

• More than 60 health, ancestry, wellness, and personal trait reports
• Reports on genetic research and new genetic discoveries
• Personalised insights based on analysis of 650,000 genetic variations
• Only service available direct-to-consumer with reports that meet FDA standards
• 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
• New and updated reports, at no additional cost, as breakthrough genetic discoveries are made

“23andMe is more than a test or series of reports – it’s a platform that offers individuals a new way to look at themselves through their genetics,” comments Andy Page, the President of 23andMe. “We have worked closely with scientists, leaders in the medical community and regulators to develop a product that provides personalised, highly relevant information to individuals.”

In addition to the new reports, features and tools, 23andMe’s Personal Genome Service provides customers with the opportunity to participate in research that holds the promise of accelerating the pace of discovery and improving 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.

At present, 23andMe only provides a partial reading of a customer's DNA, because a complete reading would be too expensive for most people. However, as seen in the graph below, whole genome sequencing costs have seen a big drop in 2015 and are now rapidly nearing the $1,000 mark. Soon, a much fuller and clearer picture of your genetic identity will be available at relatively low cost, as predicted on our timeline.

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