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23andMe replies to FDA
The company is not giving up without a fight.
This was posted to the company blog and signed by CEO Anne Wojcicki:
23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.
It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.
In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.
In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.
This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public's safety.
I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to healthier lives — a goal that all of us share.
We will provide updates as they become available.
Accordint to Techcrunch, Wojcicki also sent out a letter to customers, saying:
We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.
23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.
This was posted to the company blog and signed by CEO Anne Wojcicki:
23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.
It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.
In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.
In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.
This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public's safety.
I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to healthier lives — a goal that all of us share.
We will provide updates as they become available.
Accordint to Techcrunch, Wojcicki also sent out a letter to customers, saying:
We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.
23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.
Re: You get what you pay for
I suspect the issue is the company can't sell $99 tests that have also been conducted with sufficient regulatory rigor. And $999 tests just won't sell well enough without a very clear benefit to consumers.
Re: The problem with errors
I am not sure how come this news came after Anne Wojcicki split up from Sergey Brin, on the other hand i guess manufacturers should be asked to seek FDA approval before putting dietary supplements on the market.
Re: The problem with errors
I can see how much of a risk taking one of these gene tests could be. Imagine if you did get a false positive...
It's clear that the FDA is not yet comfortable with 23andMe. They must not think that the test is accurate enough. That being said, wouldn't you get a second opinion if you did get some sort of positive result?
It's clear that the FDA is not yet comfortable with 23andMe. They must not think that the test is accurate enough. That being said, wouldn't you get a second opinion if you did get some sort of positive result?
Game over?
Is this game over for 23andme? Does the FDA give them any out, any way to redeem themselves?
Sounds like no genetic tests = no businesses for them
Sounds like no genetic tests = no businesses for them
You get what you pay for
$99 for an individual genome analysis? It may be a case of you get what you pay for. The reputable testers say the price of effective testing has come down to about $1,000. Courtagen Life Sciences told me their test cost $999. If I paid $99 for such a test, I'd worry it would discover my nearest relative was a chimp.
Re: Unnecessary Worry and Expense
I agree that wrong information is worse than no information. I've spoken with people who believe personalized healthcare, stemming from genomics, will be the next wave in healthcare. I wonder when we'll start to see FDA-approved versions of this.
Unnecessary Worry and Expense
Very few people other than physicians have the background to interpret genetic readouts of this type, and in fact, most non-specialist physicians probably don't, either. In an era of soaring health care costs, why open a Pandora's Box containing unnecessary testing, unnecessary worry and unnecessary expense? Sooner or later, the medical infrastructure to work with this type of data will develop, and appropriate venues for performing these tests will be established. Wrong information is worse than no information!
The problem with errors
This recent blog post suggests why 23andMe data might be problematic.
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User Rank: Apprentice
1/7/2014 | 11:33:52 AM
If the Information sold by 23andMe does not live up to its promise, let the market dynamics play out - they would not stay in business if their product was not effective. This is how a free market society is intended to work.
This is similar to the way in which the FDA has been going around the country and shutting down local, PRIVATE, farming co-ops: "You can't sell milk to your neighbor unless we tell you that you can sell milk to your neighbor."