23andMe Pulls Tests From Market as Part of Warning Letter Closeout

The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related tests off the market.

The closeout letter, dated March 25, was posted online last week. “Based on our evaluation it appears that you have addressed the violations contained in this warning letter,” the letter says.

The FDA adds, however, that 23andMe should “take all necessary steps to assure sustained compliance” with the agency’s regulations.

The Nov. 22 warning letter ordered 23andMe to stop selling its 23andMe saliva collection kits and Personal Genome Service until it obtained the appropriate FDA clearances. The letter followed more than a dozen face-to-face and teleconference meetings, hundreds of email exchanges and a slew of written communications between the online service provider and the FDA, beginning in July 2009. The agency’s beef was that 23andMe never submitted clinical validation data for any of its diagnostic products, posing an unacceptable risk to consumers.

“23andMe has … agreed to discontinue new consumer access to the health-related genetic tests while it completes the submission process for FDA marketing authorization,” said spokeswoman Kendra Cassillo. She said the company is in discussions with the FDA about the kinds of data needed to demonstrate the benefits of its tests. “At this point, 23andMe cannot speculate on the timing or outcome of the regulatory review process,” Cassillo said.

Susan Laine, a spokeswoman for the FDA, would not comment on the specifics of the closeout, but confirmed that the tests cited in the warning letter are no longer being sold.

23andMe appears to be taking its regulatory operations seriously. The company recently hired Kathy Hibbs, previously general counsel at Genomic Health, to be its chief legal and regulatory officer. Cassillo said Hibbs “will play a role in the ongoing conversations between the FDA and 23andMe.”

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