[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

[Dave Sill]

http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html

23andMe Inc., the Google Inc.-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 <http://topics.bloomberg.com/mountain-view/>, California-based company
in a Nov. 22 letter<http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm>made
public today.

Wojcicki, who recently separated from her husband, Google co-founder Sergey
Brin <http://topics.bloomberg.com/sergey-brin/>, started 23andMe about six
years ago to help people assess their risk of cancer, heart
disease<http://topics.bloomberg.com/heart-disease/>and other medical
conditions. 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.
...
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.extropy.org/pipermail/extropy-chat/attachments/20131125/177eee02/attachment.html>