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Gene Tests For Everyone

Publication Date: 
May 17, 2010
Source: 
Forbes.com Blog
Author: 
Steven Salzberg

Professor Hank Greely is quoted on offering over-the-counter genetic test kits directly to consumers. Steven Salzberg of Forbes posted this story:

Pathway Genomics and Walgreens announced last week that they would start selling Pathway’s genetic testing kits at 6000 Walgreens stores. I thought this was good news – I, for one, would like to be able to run my own genetic tests. I’d like to know what risks my genes might carry, particularly if there was something I could do to reduce those risks. But what does Pathway’s test tell you, and is it worth it?

Pathway has been selling its testing kits since September, but selling them at a large chain store like Walgreens would reach many more customers. After their joint press release last Tuesday, though, someone at the FDA noticed, and stepped in to ask a few tough questions. In a letter on May 10 (read it here), the FDA told Pathway that they had to get FDA approval for their diagnostic kits, or else explain why they don’t need it. Pathway claims its kit is exempt from FDA approval, but that might be a tricky argument to prove. After the FDA sent its letter, Walgreens announced that it would hold off for now on selling the kits.

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Meanwhile, the real question is, what will Pathway’s test tell you about your genes? Some biomedical scientists are saying that the science of genetic testing is too new to offer directly to consumers. They argue that the results of a genetic test are difficult to interpret, and that patients shouldn’t be given this complex information without expert guidance. Stanford University’s Hank Greely, quoted in the Washington Post, said "Information is powerful, but misunderstood information can be powerfully bad." Are doctors just trying to protect their business, or are they right? I decided to take a look.