How the FDA Weighs in on DNA Tests

As genomics becomes relevant to medical care, regulatory agencies like the FDA are going to be watching this and making sure it’s being done properly. 

Genomics is finding its way into the news increasingly and part of the reason for that, of course, is because genomics is becoming very relevant for medical care.  For example, the Food and Drug Administration - which oversees many of the things that come into clinical care - has gotten involved in a couple of ways. 


One of the things they did was to "clear" – in other words, approve the use of one of these fancy new methods for sequencing DNA for clinical use.  These new technologies that allow you to sequence a human genome very inexpensively – the FDA now has given clearance for its use under certain clinical situations.  And then similarly the FDA is carefully watching what’s going on with some genomic testing companies, in particular some companies that are called direct to consumer companies.  

These are companies where they don’t have a health care professional in the middle ordering the test.  Rather, consumers order it on themselves. They send in a little DNA sample by spitting in a tube and then genomic information about the individual is obtained and then given back to that individual. 

The FDA is establishing exactly what they want to be doing to make sure that this is done in an appropriate fashion.  And they sent out some warnings to one of the companies and are now interacting with them to make sure that they get the information that they need in order to make sure appropriate tests are being done and they’re appropriately validated and et cetera and so forth. 

I think we’re going to see a lot more of this because as genomics becomes relevant to medical care, regulatory agencies like the FDA are going to be watching this and making sure it’s being done properly. 

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