Dec 2 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
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
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as withdrawn because the company had not responded to requests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.