By - - 0 Comments

For $99 you can find out some interesting facts about yourself. What earwax type do you have? What percent of your genes do you share with a Neanderthal? Why do you love Brussels sprouts? And of course, some more serious genetic characteristics can be observed, such as a risk of Parkinson’s, Alzheimer’s Disease, or how much blood thinner your body can handle.  Just spit into a gene kit from a Silicon Valley-based company called 23andMe, and these questions will be answered. The company sequenced the genomes of over half a million individuals for a low low price of 99 dollars until the FDA sent them a warning letter asking the company to immediately halt advertising and sales for their product.

This sounds like a great deal. For less than a hundred bucks, you can find out your risk for 254 diseases and conditions, all without having to see a doctor. The affordability and direct flow of information from company to consumer increases patients’ agency and aids in preventive medicine. Most experts in the field have acknowledged that genetics-based personalized medicine is in our near future, and cheaper genetic testing is most certainly part of this progression.

Then why has the FDA issued a warning against 23andMe? First, the company has not met the FDA’s required deadlines and did not provide enough information about the accuracy of the tests after the FDA requested it. (Can anyone say sketchy?) There are many dangers to providing inaccurate genetic testing results to the masses. People could make rash medical decisions based on incorrect information. An incorrect BRCA gene test could cause someone to have an unnecessary mastectomy or inversely choose to ignore a breast lump because of a negative test result. Studies have shown that although there is generally a standard sequencing protocol, results for one genome can differ between labs. In addition, scientists still do not have enough information about genomics. How genes interact with one another, with the environment, and cause disease are still a mystery to us. New research also constantly negates previous information, and the general population may not be aware of recent discoveries.

Will the American population be able to take these factors into consideration when they order a genome test? Will people abuse their agency and make rash medical decisions or are they able to understand that these tests cannot provide definitive answers about our bodies? Some feel that the FDA is depriving them of a personal right to their own genetic information. But if one mass media blast about a link between vaccines and autism could convince a large number of parents not to vaccinate their children (even when there is no evidence to date that this link exists!), it is very unlikely that people will be able to appropriately digest so much information about their genomes. Because it would be silly and regressive to ban cheap genetic testing, the FDA is not completely shutting down 23andMe’s operation. 23andMe has until December 13th to respond to the FDA and get its paperwork (and accuracy information) in order.

The FDA recognizes a need to create improved guidelines for genetic testing. A good compromise would likely involve a physician “middle-man” (or a genetic counselor which is a cheaper alternative) to help guide patients in interpreting the test results and in making medical decisions. Although this would likely increase the overall pricing of, and therefore access to, genetic testing, it may be the only way to responsibly progress towards personalized medicine without depriving patients of their genetic information and agency.

DNA testing FDA Warns Company to Stop Selling Cheap Genetic Tests

For More Information:

1. http://www.businessweek.com/articles/2013-11-27/do-genetic-tests-need-doctors-fda-defends-its-challenge-to-23andme
2. http://www.sci-tech-today.com/news/FDA-Tells-23andMe-To-Halt-Sales/story.xhtml?story_id=00100021A9BI
3. http://www.cnbc.com/id/101229491
4. http://www.washingtonpost.com/blogs/the-switch/wp/2013/12/01/is-the-fda-overreaching-in-the-23andme-case-readers-debate/?tid=hpModule_a2e19bf4-86a3-11e2-9d71-f0feafdd1394
5. http://online.wsj.com/news/articles/SB10001424052702304281004579219893863966448
6. http://www.huffingtonpost.com/karuna-jaggar/genetic-testing-should-ad_b_4352812.html

Photo: https://23andme.https.internapcdn.net/res/img/public/remix/8VBGQ61g14N4-jiWwL7oJA_img_kit.png