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Sunday, February 22, 2015

The Test is At Your House, The Answer May Not Be

If you were thinking about genetic testing, it is both probable and possible that your physician may not have access to much testing. There is a reluctance by insurance companies to cover such testing, and in response there has been limited information about who to test, how to test, and how to deliver the testing information. Individual companies and clinics have decided on restrictions that may be very difficult for the individual physicians to interpret, and thus there has been a barrier to such testing. In response the growth of genetic testing that is direct to patients has exploded. And you can get tested, in many cases for an affordable price, for many genetic conditions. And the FDA is slowly endorsing this. 23andme has become the first test to win the FDA approval. This not an approval the way you would think a medication gets approved by the FDA, it is a different type of classification that has determined that it can be released without specific review. The agency's move to declassify such carrier screening tests as class II medical devices, and exempting them from premarket review. But should you chose to do this test at your house, although you will get a result there may be more questions generated than answered. You may not understand the disease being tested for, how to find good information about this condition, what to say to any relatives, which physician to go and discuss this with, and how to deal with any anxiety you have over the test results.

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