The FDA has ordered the genetic testing company 23andMe to
cease selling its products.
A high profile effort to make consumer-oriented genetic testing commonplace was derailed Monday when the FDA told Mountain View-based 23andMe to stop selling its personal DNA analysis kits, claiming that the $99 tests might be based on bad science. The agency pointedly said that 23andMe, which is heavily backed by Google, has failed to fulfill many requests for proof that its test is safe and reliable, and that it provides consumers with the kind of information they need to make sound decisions about everything from cancer to dementia. The private company characterizes a customer’s relative risk for about 250 diseases and disorders based on a partial analysis of genes in their saliva. The tests -- performed with chips from San Diego’s Illumina -- also suggest how a person might respond to some medications, including the blood thinner warfarin. All results are based on scientists' limited understanding of genes.
Judging merely by my Facebook feed, most folks have been using 23andMe in the hope of unearthing some "exotic" family history, not to investigate potential susceptibility to diseases.
Labels: FDA, genetics, internet, science
