The agency told the Mountain View, Calif.-based company to halt sales of the Saliva Collection Kit and Personal Genome Service, or PGS in a Nov. 22 letter was made public on Monday. The PGS, which tells users whether or not they carry a disease, are at risk of a disease, or if they would respond to a drug. The FDA said that most of the uses of the PGS fall into the "medical device" category, and thus require FDA approval.
The FDA first made initial moves along these lines in mid-2010, when it told five companies, including 23andMe. At the time, the FDA did not request that the tests be removed from the market.
Interestingly enough, Wojcicki, recently separated from her husband, Google co-founder Sergey Brin. Brin used the saliva kit and determined he had a gene that makes him more at risk for Parkinson’s. Wojcicki started 23andMe about six years ago.
On Monday, the FDA wrote:
FDA is concerned about the public health consequences of inaccurate results from the PGS device. The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.23andMe, the FDA said, submitted FDA applications for PGS on July 2, 2012 and Sept. 4, 2012, for several of its indications for use. The FDA added, though, that:
However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(1).The accuracy test is a question in the eyes of the FDA. False positive or false negatives could cause issues for patients, as one could imagine.
It's not as though the agency hasn't tried to get 23orMe to iron out their differences. According to the letter, the FDA has had "14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" with the company.
Now, 23andMe faces a major obstacle to continued expansion (it recently began TV ads, as embedded below). If it doesn't meet the FDA's requirements, it could face sanctions including product seizures, injunctions, or major fines.