Something about this rubs me the wrong way:
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.
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. 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.”
I don't buy it. A solution without evidence of a problem? Philosophical qualms? I'm suspicious. There's more:
UnitedHealth Group Inc. (UNH), 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.
Ah... the parent company of everyone's favorite, United Healthcare. And what exactly is their interest in this? My interactions with them don't indicate that they do anything out of the goodness of their hearts, which is their right, but they don't pay for these tests and no treatment of their customers would be paid without their approval.