well now, let’s see why they REALLY are demanding this product be pulled….hmmmm, proponents of personalized medicine???  yeah right!-A.M.

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Posted: 11/26/13 8:18 AM


Technology advocates often say that regulators just can’t keep up with what they’re doing. But sometimes the companies can’t or won’t make the case for their products to government officials.


The latter seems to be the case in a dispute between the Food and Drug Administration and the personalized genetics company 23andMe which led the agency to tell the company on Monday that it must stop marketing its hallmark personal DNA sequencing kit. After informing 23andMe in 2010 that it would have to seek approval for its product, the agency informed the company in the most recent letter that it considers that petition withdrawn because the company has failed to provide follow-up information the FDA required.


It appears to be 23andMe’s new TV marketing campaign that pushed the FDA to take the regulatory action.


23andme-kitIn its television ads and on its website, 23andMe claims that its personal DNA sequencing service provides customers with information about their genetic health risks and likely responses to pharmaceuticals. The FDA classifies the test kit as a medical device, but 23andMe has claimed that it offers a laboratory test.

23andMe and its defenders often hail the company’s exome sequencing kit as a revolutionary product that will help realize the goal of personalized medicine. Ironically, the company proposed that the kit be approved as a test similar to those already on the market. Such approval would have meant a shorter pathway to approval.

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