BIOL 1610
After years of tug-of-war with the FDA, the ban on selling DNA tests has finally been lifted for unique genetic company 23AndMe. Individuals partaking in the tests can discover risks for developing 10 different disorders, using a simple at home genetic test.
Based in Mountain View California, 23AndMe is a unique service that individuals can order, and send back with a swap of saliva in hopes to receive interesting genetic information. Weeks later, users receive an email describing what their DNA says about them including traits and ancestral information. Beginning in 2006, 23AndMe could also release certain risk factors to developing 240 different health conditions based off of the DNA testing done. The FDA decided to stop this element in 2013, because they were concerned individuals would make important medical decisions based off of the test, regardless how uncertain they were.
Two years later, the FDA allowed results to share whether users children could develop any of 36 diseases. Test results however would not reveal risk factors of the individual's risk of developing each disease. The company vicariously continued their works in hopes to one day get the green light to sell actual DNA tests for specific diseases.
Today, the FDA has finally allowed 23AndMe to determine a person's own risk at developing certain diseases. Consumers can now know up to 10 genetic conditions they have a chance of receiving, including Alzheimers, Parkinson's Disease, Thrombophilia and Coeliac Disease. Such results should not be mistaken for a medical diagnosis, because given factors such as lifestyle and environment play a role in chances of development. This ruling is said to reduce the chances of other companies searching for loopholes around the US Governments requirements for genetic testing, showing that going through the FDA can be a step in the right direction and a way to move forward. 23AndMe will start selling DNA tests in the near months to come. Kathy Hibbs who is an officer at 23AndMe says,"We are really tired and really happy." The long-awaited action is finally in company's favor.
Hank Greely, a bioethiest at Stanford University worries individuals may need help from a genetic coach or counselor in order to correctly understand the information given from the test, as other companies begin to offer the same kind of tests.
When participating in a 23AndMe test, it tells users if any other of their siblings also partook in the program. I have a friend who sent in her swab of spit, and 6-8 weeks later found out her sister also took the test in search of her ancestry information. Except my friend wasn't aware she even had a sister, since she grew up as an only child. After she confronted her parents, it ended up being the best thing that happened to them and completely reunited the family!
- Lindsey Tanner
http://www.nature.com/news/23andme-given-green-light-to-sell-dna-tests-for-10-diseases-1.21802
I am a huge fan of genetic research, and I really hope we can deregulate it further so that we can get to the real research with things like cancer and Alzheimers. However, I am a bit concerned about the tests from 23 and me. With the discovery of the CRISPR method (the use of which I sincerely hope is only further deregulated and encouraged) the highest cost to genetic research and engineering is now in the DNA analysis realm. The biggest obstacle to making genetic therapy treatments viable is the fact that to get a single persons genome costs between one and two thousand dollars right now. Because of the high demand there is a lot of effort in lowering that cost, but I worry that 23 and me is misdirecting efforts and may lead to public distrust of genetic testing. The problem is that while like any medical test the 23 and me tests can narrow down the possibility of having genetic diseases, it simply isn't accurate enough and is still too expensive to be useful. Rather then analyzing a persons entire genome, 23 and me works by analyzing 8 easily identifiable "Short Tandem Repeats," or STR's, to approximate that persons genetic heredity, and then compare the rates of other people who have similar genetic heritage to determine the likelihood of you having a genetic disease. Anyone who has familiarity with Bayes Theorem can see the problem here.(if you don't I highly reccomend looking it up, or reading this: https://arbital.com/p/bayes_rule/?l=1zq ) The concern is that people may come to associate the "genetic testing" with being inaccurate, which in this case it is. It is true without a doubt that it was ridiculous for there to be any reason for 23 and me to not be legal, as its information is completely useless to genetic engineers and only works for identifying weak correspondence with genetic heritage.
ReplyDelete-Tyler Henderson
I found this article really interesting. Just like Tyler mentioned above I find genetic research really interesting, and when it is used to help finding with cancer and Alzheimers research it make it even better. I also find it really great when people want to look more into their heritage. I find it very neat knowing where you come from and who were your ancestors. Although I like the idea of this I would have to say, I couldn't believe the results completely because I wouldn't be able to see the process being done. Plus when sending in your DNA you don't really know what they do with it. I would do so much research before sending in anything.
ReplyDelete-MS