Hi All,
FYI, this past November 2013, the FDA halted the
23andMe personal genome testing service due to the questionable accuracy of their test results.
The company had been marketing their personal genome test as "medically diagnostic." The FDA's concerns were related to the risks, benefits, and limitations of these tests -- issues that were never mentioned on the company's website, and could mislead individuals relying upon their test results. They have not yet come forward with answers to the FDA questions about their testing.
Here's an article link to the story of one woman's experience (a New York Times reporter) with personal genome testing --
http://www.nytimes.com/2013/12/31/science/i-had-my-dna-picture-taken-with-varying-results.html?_r=0.
It's an interesting article that reflects the potential problems that arise with this type of testing. In fact --
all test results -- not only genetic tests -- must be looked at from a broad perspective. A positive or negative result on a single test is meaningless -- unless the entire picture is examined.
23andMe had been mentioned by a few forum members a while back. They had purchased the company's saliva test kit, which was advertised as a "reliable test for genetic susceptibility" for numerous inherited conditions. At least one POIS forum member was advised that his test result showed a mutation on the
MTHFR gene.
The presence of a gene mutation does not mean that a person is affected by a specific genetic condition, or is even at risk to develop the condition! There is a tremendous interplay between genes, the proteins they produce, and environmental factors. This interplay was not taken into account in the 23andMe test results.
For now,
23andMe can only market their genome testing to potentially help trace ancestral history.
If the company does decide to answer the FDA's questions -- which they must do by law because they were selling their product as a medical diagnostic -- then perhaps they will once again be able to market their genetic test.
Unfortunately, genetic testing is far from simple, usually takes a few months to process, and is quite an expensive process. Most importantly, the results must be evaluated by a trained geneticist.
Take care, everyone!
Stef
