23andMe, the Google-backed DNA analysis company co-founded by
Anne Wojcicki, was told by U.S. regulators to halt sales of its
main product because it's being sold without "marketing clearance
or approval."
The Saliva Collection Kit and Personal Genome Service, or PGS,
tells users whether they carry a disease, are at risk of a disease
and would respond to a drug. Most of the uses fall into the
category of a medical device and require Food and Drug
Administration approval, the agency told the Mountain View,
California-based company in a Nov. 22 letter made public today.
YouTube testimonial for 23andMe
Ms. Wojcicki, who recently separated from her husband, Google
co-founder Sergey Brin, started 23andMe about six years ago to help
people assess their risk of cancer, heart disease and other medical
conditions. Mr. Brin used the saliva kit to determine he had a gene
that makes him susceptible to Parkinson's.
"FDA is concerned about the public health consequences of
inaccurate results from the PGS device," the agency said today.
"The main purpose of compliance with FDA's regulatory requirements
is to ensure that the tests work."
The FDA decided in 2010 that services claiming to evaluate a
customer's risk of disease must be cleared by regulators if the
companies sell directly to consumers. Most FDA-cleared genetic
tests are for a single disease while 23andMe's would be the first
to test for multiple conditions.
"We recognize that we have not met the FDA's expectations
regarding timeline and communication regarding our submission,"
Catherine Afarian, a spokeswoman for 23andMe said in an e-mail.
"Our relationship with the FDA is extremely important to us and we
are committed to fully engaging with them to address their
concerns."
23andMe submitted FDA applications in July and September of 2012
for the least stringent of two types of medical device reviews. The
FDA said the company failed to address "the issues described during
previous interactions."
UnitedHealth Group, the largest publicly traded U.S. health
insurer, raised concern in a March 2012 report about the accuracy
and affordability of the tests. Such types of genetic tests may
become a $25 billion annual market in the U.S. within a decade,
highlighting the need to identify which work best, the insurer said
at the time.
