23andMe CEO Discusses Company’s Future

11-25-2013 9-29-43 PM

Six months after the FDA’s widely-publicized decision to shut down sales of 23andMe’s medical-oriented genetic testing product because it was operating without the necessary FDA approvals, the company has yet to return to business as usual. This week, 23andMe CEO Anne Wojcicki sat down with The Chronicle to discuss the company’s future and the evolving personalized genetics industry at large.

The core issue for the FDA is 23andMe’s Personal Genome Service, or PSG, a $99 genetics test that is used to create a genetics-based risk profile, highlighting the persons likelihood of  eventually developing conditions like Alzheimer’s Disease, Cystic Fibrosis, and various cancers. 23andMe relies on DNA analysis of user-submitted saliva samples to deliver this service, using the genetic data to calculate risk-levels for 240 different diseases.

In a November 2013 letter, the FDA questions the clinical reliability of the risk profiles being generated, and in November instructed the company to stop selling the report until it submitted test results that would scientifically validate that the information being provided to consumers was medically accurate. The letter went on to say ““Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.”

Since that time, 23andMe has pivoted its marketing strategy toward providing ancestry data, rather than medical data, and has continued selling the PGS service under this new role. In the meantime, CEO Anne Wojcicki confirms that they cannot do any health interpretation until they complete the FDA’s required pre-market applications. She says “We’re working with the FDA to find the right path forward, and that’s part of what we’re figuring out. We had filed two (applications to sell medical devices) with them before, so we’d gotten a lot of feedback, and there was a number of projects and studies they wanted us to do. So we’re following up on everything that they wanted us to do.”

When asked if the company had considered marketing the device overseas, where some suggest they might bring PGS to market more quickly, Wojcicki confirmed that 23andMe does want to grow to provide medical testing services globally, and that it already sells an abridged version of its genetics kits in 12 countries, but for the moment she says nothing firm is the works. In general, she says that the US is falling behind in the race to adopt genetics testing, “I think the U.S. is falling behind. There’s massive government initiatives going around the world and you see that there’s a real enthusiasm for genetics.”

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