FDA Lift Restrictions On 23andME

The New York Times published an article "F.D.A. Reverses Course On 23Andme Dna Test In Move To EaseRestrictions." The article discussed 23andME, which is a genetic testing company and in late 2013 the company had to stop offering health-related testing with the genetic tests because of the FDA. The FDA said that they needed their approval before they could market the results. But just recently the FDA gave approval for the information to be released in regards to a rare disorder, Blood syndrome. Along with this approval, they also got the go-ahead, in general, carrier tests. 23andME declined the statement that they would offer health information again at the moment, but hope they can once again soon. They also have deals with Pfizer and Genentech, where they do research with the data obtained from the company’s customers. The carrier test is that if two people are a carrier for a certain disease, then their child has a chance of getting the disease, such as with cystic fibrosis and Bloom syndrome. If the carrier test shows that both parents are carriers then the parents can take that information into consideration. The Bloom syndrome test was approved by demonstrating the accuracy of the carrier test.

The whole idea of 23andME in general is really cool to me, and after we talked about it in class it really made me want to do one for myself as well. And in class we mentioned that the problems they were having with putting up the health risks for individuals, which I think could be very helpful and insightful. So, the fact that they are gaining approval from the FDA is a great thing because many people can benefit from these findings. Especially with the carrier tests, since they showed how accurate the test was. And if people are not very concerned about their health risks enough to go to a doctor, it could be beneficial to go onto 23andME and they can see their risks and if they see anything alarming then they could consult with a doctor. Overall, I really like the concept that 23andME encompasses.