Nov 25 The U.S. Food and Drug Administration has
warned 23andMe Inc, a company backed by Google Inc, to
halt sales of its genetic testing services because they have not
received regulatory clearance.
23andMe, which was founded in 2006 by Anne Wojcicki with the
backing of Google, sells DNA testing services that the company
says detect a range of genetic mutations and provide information
about a person's health risks. Wojcicki recently separated from
her husband, Sergey Brin, a co-founder of Google.
In a warning letter dated Nov. 22 and released on Monday,
the FDA said it considers the company's product a medical device
that therefore requires regulatory clearance, "as FDA has
explained to you on numerous occasions."
The privately held company, which is based in Mountain View,
California, did not immediately respond to a request for comment
left before business hours.
The FDA said some of the intended uses of the company's
Saliva Collection Kit and Personal Genome Service (PGS) are
particularly concerning, including risk assessments for certain
The agency said that if the company's risk assessment for
breast or ovarian cancer reports a false positive, it could lead
a patient to undergo preventative surgery, intensive screening
or other potentially risky procedures. A false negative, on the
other hand, could result in a failure to recognize actual risk.
The FDA said in its letter that the company submitted
applications in July and September of 2012 for several of these
indications for use.
"However," the FDA said, "to date your company has failed to
address the issues described during previous interactions with
the Agency" or provided additional information requested. As a
result, the FDA said the applications "are considered
The agency said it had been "diligently working" to help the
company comply with the law, and has spent significant time
evaluating the intended uses of the product. It said it also
provided detailed feedback to the company regarding the types of
data it needed to submit. The agency said its interactions with
the company included more than 14 face-to-face and
teleconference meetings, hundreds of email exchanges, and dozens
of written communications.
"However, even after these many interactions with 23andMe,
we still do not have any assurance that the firm has
analytically or clinically validated the PGS for its intended
uses," the FDA said.
The company's name refers to the 23 pairs of chromosomes
that make up each individual's genome.