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

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, California-based company in a Nov. 22 letter made public today.

“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.”...

...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.