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 Posted 12/6/2013 7:11:22 PM
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Unfortunately thanks to the FDA new customers of 23andME will no longer get health-related genetic results.

The following is an e-mail sent to 23andME customers today regarding the issues it is currently having with the FDA:

Dear 23andMe Customers, 

I'm writing to update you on our conversation with the U.S. Food and Drug Administration and how it impacts you. 

If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have. 

23andMe has complied with the FDA's directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency's regulatory review processes. Be sure to refer to our 23andMe blog for updates.

We stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 - known as CLIA. These are the same standards used in the majority of other health and disease-related tests. 

You are among the first people in the world to ever get access to their genomes. You are genetic pioneers. Thank you for your ongoing support and we look forward to continuing to serve you. 

Anne Wojcicki
Co-founder and CEO, 23andMe
Post #11098
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 Posted 12/6/2013 7:31:38 PM
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You can still order genetic tests that give you raw results you'll have to research and interpret yourself, I understand. They just no longer can offer any interpretation outside of ancestry.
www.23andme.com/store/cart/



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Post #11099
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 Posted 12/7/2013 1:23:52 AM
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Perhaps LEF can supply the missing interpretation of the results....
Post #11100
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 Posted 12/7/2013 9:29:12 AM
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Transpower (12/7/2013)
Perhaps LEF can supply the missing interpretation of the results....


There already are some alternative software tools for interpreting raw SNP data:

SNPedia's Promethease: http://en.wikipedia.org/wiki/SNPedia
dbSNP: http://en.wikipedia.org/wiki/DbSNP

The tide of change does not appear to favor the FDA's position, but you know that as a powerful regulatory agency they will not cede what they believe is their statutory authority without a serious fight.
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 Posted 12/7/2013 2:08:06 PM
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Transpower:  It might be considered medical advice. 
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 Posted 12/8/2013 12:37:36 PM
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DDye:  Maybe LEF could hire a regular M.D. to review results of 23andMe for members of LEF.  I think this is an important test.


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 Posted 12/9/2013 2:56:21 AM
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I'm afraid the MD would be breaking the same rules. We have a FDA that struggles to enforce truthful labeling statutes as it spends so much time protecting monopolies and marching in the pharma army. 

What percentage of our imported food is actually inspected by the FDA? Domestic food?
Does the FDA actually perform assays on supplements to verify ingredients? 
Is all the factory food being tested for toxins and/or contaminants by the FDA?

I'd bet the FDA has more lawyers than scientists...What are we really being protected from and how much does it cost?
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 Posted 12/9/2013 4:04:08 AM
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It would be hard to know all that goes on with this agency.  It is my belief that we need the Food and Drug Administration, and since this is an organization that we fund with our tax dollars, we have a right to know and should have some input concerning its policies.

To answer one of your questions, they do perform inspections, but it would be impossible to inspect everything people put on or in their bodies.  There is some degree of trust in doing business with others that we as the public still have.  And although a certain amount of protection is desirable, there are some risks that people are willing to take, and some risks that are unknown. 


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 Posted 12/9/2013 4:24:12 AM
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Much of the "health-related genetic results" are simply probabilities of developing different medical condition relative to average, (i.e. 17% or 1.5 times normal rate). This looks a lot like the results one obtains from things like an online heart attack risk calculator. If the FDA wants to be consistent then it should probably ban websites (including the American Heart Association) from providing these calculators.Doze
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 Posted 12/9/2013 4:58:05 AM
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I think the FDA is treating us like children here.  I'm an adult--I'm free to accept or reject the conclusions of 23and Me and any other medical assessment.  Big government infantilizes the public.
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