FDA Shuts Down 23andMe’s Genetic Testing Service

11-25-2013 9-29-43 PM

The FDA has sent a public letter to genetics testing company 23andMe over the company’s persistent failure to submit test results that would scientifically validate the tests accuracy and allow the FDA to either approve or deny a 501(k) application that was originally submitted in July 2012.

At the root of the issue is 23andMe’s Personal Genome Service, or PGS. 23andMe markets the $99 service as a personalized genetics test that its website claims will “helps you know more about your health so you can take an active role in managing it.” Once ordered, 23andMe mails a saliva collection kit to the customer. Saliva is collected, mailed back to 23andMe, and then used to evaluate “over 240+ health conditions and traits.”

After sequencing, a report is sent back to the customer outlining genetic health risks, such as a predisposition to Alzheimer’s disease, or breast cancer. The report also quantifies a patients carrier status across a variety of genetic conditions, such as Cystic Fibrosis and Sickle Cell Anemia, information that is intended to help parents understand what genetic health risks their children may have inherited from them.

The report also analyzes genetics-based drug responses, as the website says: “With 23andMe, you and your doctor can get a better idea of how you might respond to certain medications.” Details within the section are marketed as being able to help a physician determine whether more or less of a medication would be needed, or whether an alternative medication might be a better choice.

The FDA took issue with 23andMe’s marketing of in this way, explaining in the letter that was posted to their website that “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.”

23andMe has had a highly public and highly praised run thus far. The company was launched in early 2007 and began offering DNA testing services in November of 2007. The same year, they raised a $3.9 million series A round led by Google. In 2008, 23andMe’s saliva-based genetics test was named “Invention of the Year’” by time magazine. The same year, both New York and California attempted to block the sale of the tests based on improper licensing, but by the end of 2008, 23andMe had secured the necessary state licenses to continue operations.

In 2009, the company’s involvement with the FDA began. The FDA’s letter explains “Since July of 2009, we have been diligently working to help you comply with regulatory requirements….As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.”

The years of back-and-fourth between 23andMe and the FDA came to a head this week when the company received notice that it was being ordered to halt marketing of its personal genome service until it secures FDA approval. Despite the outstanding issues, 23andMe responded to the letter quickly and publically, taking ownership of its failures, and ensuring the public that it would complete the necessary steps to finalize FDA approval.

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