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Animation of the structure of a section of DNA. The bases lie horizontally between the two spiraling strands. (Photo credit: Wikipedia)[/caption]By now I'm sure that many of you have seen the news that the DNA testing company, 23andMe, has been ordered by the FDA to cease and desist. Not a good sign! The government has been trying to get them to cooperate with a few demands that, in my opinion, are quite reasonable. Apparently this has been going on for a while. I plan on doing a little more reading about it and adding the information to this post. From what I understand so far, the crux of the matter is that the government wants them to explain how they disseminate the results of the DNA studies to people who may or may not use the information properly without the advice of a doctor. What if there's a false positive in a BRAC1 or BRAC2 test for breast cancer. The resulting anguish would be inexcusable until a doctor ran the appropriate tests. Worse, if the test was a false negative, how long would someone who actually had the faulty genes go without getting a more thorough, doctor supervised test/exam?
It's a big deal, for sure. And there'll be much more about this. There a millions of investment dollars at stake, not to mention the pall cast over the entire commercial DNA testing industry.
Stay tuned!
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Fda (Photo credit: Wikipedia)[/caption]Related articles
- FDA halts sale of 23andMe DNA tests (utsandiego.com)
- Stop selling those DNA tests, FDA tells 23andMe (nbcnews.com)
- FDA orders 23andMe to halt sales of DNA test kit (theverge.com)
- FDA: 23andMe must stop selling DNA test kits (mercurynews.com)
- Genetic Test Service 23andMe Hits Roadblock - Wall Street Journal (online.wsj.com)
- FDA Demands a Halt to a DNA Test Kit's Marketing - New York Times (nytimes.com)
