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View Poll Results: Does FDA has the right to regulate this product? (genome interpretation services)

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Old 01-24-2016, 08:04 PM   #1
Mr. Questionman
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From Wikipedia...

23andMe is a privately held personal genomics and biotechnology company based in Mountain View, California. The company is named for the 23 pairs of chromosomes in a normal human cell. Its saliva-based direct-to-consumer personal genome test was named Invention of the Year by Time magazine in 2008.

In 2013 the US Food and Drug Administration (FDA) ordered 23andMe to discontinue marketing its personal genome service (PGS) as the company had not obtained the legally required regulatory approval resulting in concerns about the potential consequences of customers receiving inaccurate health results. The company continued to sell a personal genome test without health-related results in the United States until October 21, 2015, when it announced that it would be including a revised health component with FDA approval. 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014, and in the United Kingdom since December 2014.

The company is unable to give people any medical interpretation of their genome. Which makes the whole thing useless. Though you can download the genome and upload to other sites that haven't been banned from this yet.

Recently they got approval for a very small number of tests which they can report.

A Note to Our Customers Regarding the FDA

The FDA has no right to regulate this product. It is a stretch of the law to include it within thier perview and we would all be better off without this agency.
Its a pity that the FDA destroyed the valuable source of actionable genetic health information that 23andMe used to provide. I am afraid that any FDA regulated interpretation of genetic data, i.e. the "acceptable interpretation", will never amount to anything useful.

Fortunately, one can take the raw data to promethease and get a comprehensive report that contains high quality, actionable information. Unfortunately, it does not appear to be possible for this to be tied in with the kind of statistical data collection, via user surveys, that 23andMe used to do.... actually they still do, but since I don't log in to 23andMe for my health info, I don't do the surveys either.
When my iron came back high from a health fair at work, I did some research and found out about hemochromatosis. I checked my 23&me results from almost 2 years ago and found that two C282Y mutations were present in my DNA. Bringing that information to my doctor helped us to quickly decide on further blood tests and were able confirm that I have hereditary hemochromatosis. Thank you, 23&me in making my DNA information available to speed up treatment for this common but not easily diagnosed genetic disease. I hope that the FDA sees the value of your service.
The FDA has no right to regulate this product. It is a stretch of the law to include it within thier perview and we would all be better off without this agency.
The whole thing is crazy, it's just information. I can get similar information by paying for academic journals.

23andme will not survive if they have to go through a regulatory process for all new information they put up on their website. Either move the company, our be outcompeted from someone outside US.
That's a government running exactly and precisely backwards. A government of the people, by the people, and for the people should give rights priority to the people governed. The rights should not be to other third-party and government entities. Period.

We are not asking a government entity, or a medical "professional" or any other group or individuals to pay for or take responsibility for our buying and accessing this information. This is information I want about me. The handcuffs should be on the doctors, the government, and the other organizations that seem to be interested. They should be the ones that do not have access to information about me. They should not be the gatekeepers of the information about me.
Just move everything to Ireland like all of the other companies, until the USA changes.


Updated on 10/23/15

23andMe Is Back in the Genetic Testing Business With FDA Approval

23andMe will start giving customers health data again after limited FDA approval

23andme relaunches its expanded DNA spit tests after FDA-mandated pause
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