Dec 2 (Reuters) - Home genetic test maker 23andMe, which is backed by Google Inc, stopped marketing its products last week after the U.S. Food and Drug Administration warned that it did not have regulatory approval to do so, a company spokeswoman said.
The company stopped television, radio and online advertising for its $99 DNA test which is supposed to detect a range of genetic variants and provide information about a person’s health risks, the spokeswoman said.
The FDA said last week it had sent a warning letter to the company on Nov. 22 stating that products designed to diagnose, mitigate or prevent disease were medical devices that required regulatory clearance.
The agency also said false positive tests for certain breast or ovarian cancers could lead a patient to undergo preventative surgery including mastectomy, intensive screening or other potentially risky procedures. A false negative could result in a failure to recognize and act on an actual risk.
Company founder Anne Wojcicki said in a Nov. 26 blog post that the company had been talking to the FDA since 2008 and had submitted its first application for clearance in July last year, followed by another submission in September.
She said the company had received feedback on the submissions and was behind in its responses.
“We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well,” Wojcicki wrote in the post.
The FDA in its warning letter described those applications as withdrawn because the company had not responded to requests to provide additional information.