Saturday, Apr 19, 2014Saturday, Apr 19, 2014

Genetic test maker 23andMe stops marketing after FDA warning

Published on Dec 3, 2013 9:48 AM

(REUTERS) - Home genetic test maker 23andMe, which is backed by Google, stopped marketing its products last week after the US Food and Drug Administration warned that it did not have regulatory approval to do so, a company spokeswoman said.

The company stopped television, radio and online advertising for its US$99 DNA (S$124) test which is supposed to detect a range of genetic variants and provide information about a person's health risks, the spokeswoman said.

The FDA said last week it had sent a warning letter to the company on November 22 stating that products designed to diagnose, mitigate or prevent disease were medical devices that required regulatory clearance.

The agency also said false positive tests for certain breast or ovarian cancers could lead a patient to undergo preventative surgery including mastectomy, intensive screening or other potentially risky procedures. A false negative could result in a failure to recognize and act on an actual risk.

If you are not a subscriber, you can get instant, unlimited access here