FDA Drives Medical Innovation Overseas As 23andme Looks Elsewhere To Help People

Last Fall, the FDA blocked the personal genetic profiling offered by 23andMe, stopping the sale of the company’s home genetic testing kits in the U.S.  At the time TechFreedom issued a plea:

We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.

We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of hamstringing new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.

23andMe, fearing that the FDA will take years to evaluate the product, has given up on the U.S. for now and is looking to help people in overseas markets.  Keep in mind that 23andMe is providing your own personal genetic data that alerts you potentially interesting genetic variants.  The company strongly encourages customers to consult with their doctor for any additional testing and advice that might be warranted.  So it is not, technically, providing a diagnostic.  That said, widespread use of their inexpensive technology would be a great way to build awareness of genetic information and its limitations.  It could potentially provide a useful data set for further study, at a very low overall cost.  Well, perhaps in other countries, anyway.

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