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23andMe Wins FDA Approval for New Genetic Test


In the past, the FDA has expressed worry that consumers might misinterpret at-home genetic tests, leading to improper decisions without physician guidance. This is why 23andMe was forced table one of their personal genome tests in November 2013. It’s been an uphill battle, 23andMe’s leaders say.

That’s also why, when the FDA granted direct-to-consumer marketing rights for 23andMe’s Bloom Syndrome carrier test last week, the news felt so good. The agency is also requiring that 23andMe supply information on obtaining geneticists for pre- and post-test counseling.

So what has changed for the FDA since late 2013? A lot, it seems.

“The FDA believes that in many circumstances, it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

“These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”

Anne Wojcicki, CEO of 23andMe, and Andy Page, President of 23andMe, recalled the aftermath of the FDA’s 2013 Warning Letter in an interview with the SF Chronicle. “Andy and I would sit here and be like, ‘We just don’t even know what direction to go because there’s just so many uncertainties’,” Wojcicki said.

However, this initial setback only ignited the team’s mission to change the world through genomics and patient empowerment even more extensively. “Anne sets the tone for the company,” said Angela Calman-Wonson, vice president of communications. “We believe that helping people access, understand and benefit from the human genome will have a profound impact on our health and how we live our lives.”

23andMe’s next big push for FDA approval came in June 2014 with the Bloom Syndrome report, which focused on a single rare inherent condition. This time, they treaded lightly alongside the agency: “This is really kudos to the FDA for putting in a tremendous amount of effort and time to create a path forward for direct to consumer genetic testing.”

Now, with FDA approval in their pocket, 23andMe is poised to lead the scientific industry in opening doors for additional opportunities in personalized, at-home genomic services.

For many healthcare services like 23andMe, it’s not just about providing consumers with information transaction, either. It’s also about having access to data on human conditions in micro and macro scale, which in turn can be used for drug discoveries. Although the FDA has not yet cleared the company for direct HCP engagement with health care information, they are collaborating with some biotech giants with plans for research-based data sharing.

Of course, privacy and regulatory processes continue to be a necessary impediment, but research shows that consumers want greater empowerment and access to their health information. “Our customers are extremely engaged,” Calman-Wonson said on their plans to continue expanding their offerings. “They not only want to learn more about themselves by exploring their DNA, but many want to help advance genetic research – more than 80 percent of our 850,000 customers consent to participate in research. We are incredibly grateful for all of our customers, and for their support over the years.”

Shreya Iyer

Shreya Iyer

    Shreya specializes in health communications and is a copywriter for an advertising agency. She was previously at Bayer Healthcare, Janssen Pharmaceuticals and Ogilvy CommonHealth Worldwide

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