23andMe, the highest profile genetic testing company, co-founded by Anne Wojcicki, wife of Google co-founder Sergey Brin, has gotten a warning letter from the FDA. The problem? They don't disclose how accurate they are, but they claim all kinds of awareness benefits that make them look a lot like a medical device.
The FDA is so unimpressed by Google money they even spell her name as "Ann". Google and Yahoo are now encrypting a lot of user data to prevent the rampant spying the current administration has been engaged in but it is unlikely this is a return salvo in a war against the search engine giant.
They specifically cite a lack of clarity about its accuracy regarding BRCA-related genetic risk and drug response, along with claims they can to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. They say they have been trying to see some proof since 2009, which is a year after we started expressing concern about direct to consumer genetic testing services.
Hey, at least they aren't saying their genetic testing will find them a better lover. In 2010, the GAO sent undercover patients to various companies (they did not disclose the names) where they were told these tests could help with repair DNA repair and that supplements based on test results could cure diseases and other rubbish.
This isn't the first time 23andMe has refused to use what we might call a standard form of ethics. In 2010, hey came out and said they were not bound by informed consent rules for the use of genetic data in a journal paper because they did not use human subjects - there was no contact between the investigators and the people whose biological information were being used. And we have been wondering since 2008 when the FDA or someone was going to crack down on the batty claims companies are making, like that knowing your genetic roadmap will help you live longer.
The letter is about "compliance" and the FDA is in no rush, since they have been asking for 18 months. The IRS is really the only part of government you can't screw with. If you file your taxes late, they will assess the penalties and put a lien on your bank account within weeks. But if President Obama ignores federal court orders about Yucca Mountain, 23andMe can ignore the FDA.
As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.The FDA says it is being marketed as a medical device and has to follow the rules. 23andMe is now in the uncomfortable position of choosing between being regulated or saying their test is 'just for entertainment.' Their page on celiac disease says it is 57-87% genetic, which is so broad they could say that is entertainment rather than scientific.
Instead of providing documentation since being asked years ago, 23andMe has redoubled its marketing efforts. James L. Woods, Deputy Director of Patient Safety and Product Quality, now says they have three weeks to comply - and hinted at "seizure, injunction, and civil money penalties."
Letter to 23andMe, Inc. from the US FDA 11/22/13
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