First came the letter from the FDA. Signed Nov. 22 by Alberto Gutierrez, director of the Office of Invitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health, the letter warned the company that it was marketing its "Saliva Collection Kit and Personal Genome Service (PGS) without clearance or approval in violation of the Federal Food, Drug and Cosmetic Act."
"Specifically, the FDA is concerned with the unsubstantiated medical claims being made by 23andMe," FDA spokeswoman Susan Laine said in an email. "Results from this test may lead consumers to make major medical decisions that may be irreversible without input from a qualified health care professional."
Then came the lawsuit. Filed on Nov. 27 by Lisa Casey in the U.S. District Court, Southern District of California, the suit cites "unfair business practice" and "false and misleading advertising."
Representatives from the Mountain View-based 23andMe aren't saying much. They declined to comment on the class action suit.
Following reports that the company continued to market and sell its Personal Genome Service product after receiving the FDA's letter, two separate spokeswomen for the company would only say that 23andMe has stopped marketing its product after receiving a warning letter from the Food and Drug Administration.
"23andMe halted all marketing last week in accordance with the FDA's instructions," said Tracy Gale of the public relations firm WCG in an email to the Voice, echoing another spokeswoman's response. Neither mentioned anything about the company continuing to sell its products.
After that, both women referred the Voice to a brief statement on the company's website: "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
That statement came in response to Gutierrez's letter, in which he indicated that he remained skeptical of the company's service. While the Personal Genome Service is marketed as a tool to empower consumers — by informing them of certain genetic risks and providing them with knowledge that would help them make better treatment choices — Gutierrez wrote, "we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses. ... Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."
FDA spokeswoman Laine noted that the administration has been in contact with 23andMe since July of 2009, and has repeatedly expressed concerns about the company's products. "However, after numerous interactions with 23andMe, including as recently as January 2013, the FDA still does not have any assurance that the company has analytically or clinically validated the test for its intended uses," Laine wrote.