Genetic testing evolves, along with health and ethics debates
By Michael Hiltzik,
Los Angeles Times
| 10. 30. 2015
Untitled Document
When last we visited with the genetic testing firm 23andMe, it was in big trouble.
That was in December 2013. The Food and Drug Administration had just ruled that the company had been breaking the law in marketing its Personal Genome Service. For $99, customers spit into a tube, mailed it to 23andMe and got back a report on their carrier status or susceptibility to breast cancer, heart disease and some 250 other diseases or conditions, based on genetic information extracted from their saliva.
The FDA described the service as an unlicensed medical device and ordered it off the market. Its warning letter implied that the Mountain View, Calif., company hadn't been straight with regulators and was ignoring demands for data proving its service was accurate. Experts in the genetics testing field wondered whether the tests — and the company itself — were ready for prime time.
As of mid-October, 23andMe is back in the direct-to-consumer genetic testing business. (The firm's name refers to the 23 chromosome pairs in the human genome.) It's selling a different product, one...
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