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23andMe Gene Test Banned by FDA Is Now Available in the U.K.

23andMe


A little more than year ago, the genotype screening test offered to consumers by 23andMe was banned by the FDA on wholly specious grounds. As a long-time customer I was happy to get some test results indicating some genetic disease risks and possible reactions to medications. For example, my 23andMe results tell me that I have gene variants that suggest that I have an elevated risk for Type 1 diabetes and that I am at lower risk for Alzheimer's disease. Also, some variants suggest that I am a rapid metabolizer of proton pump inhibitors used to treat heart burn.

As it happens I am not at all diabetic (with rock solid glucose test results to prove it). I also did not suffer heart palpitations upon learning that I carry alleles that indicate a higher risk for developing atrial fibrillation.

In its banning letter, the FDA cited not a single example of harm stemming from 23andMe's tests.

Now the company is evidently being permitted to sell its services and offer its health risks test results to the good folk of Great Britain. From the Guardian:

Genetic testing company 23andMe is launching its personal genome service in the UK after it was banned in the US. The service allows people to send their saliva in a testing kit to have their DNA screened for genes associated with certain inherited conditions, such as cystic fibrosis or sickle cell anaemia, and other genetic markers relating to parts of their lives and ancestry. "We can take complicated genetic information and distill it in language that people can actually understand," the 23andMe chief executive Anne Wojcicki said. "The genome is fascinating, and it's the most exciting scientific revolution of our lifetime. The goal is to keep people engaged with their own genome, so that they know what it means for them and then keep them abreast of the scientific discoveries as they unfold." The spit kits cost £125 and are sent to the Netherlands before testing in the US. The results, which take approximately six to eight weeks, allow users to both browse the raw code of their genome and use tools to investigate their genetic makeup.

Will some Americans try buying the service from the U.K. now?

In any case, 23andMe will still send you the raw results of your tests that can then be loaded into Promethease for $5 and the system will put together a pretty readable personal DNA report based on the scientific literature cited in SNPedia.

In fact, if you are having a lazy afternoon, click on over to SNPedia where I have put my gene testing results up for anyone to browse through.

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