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Re:Genetics prof: Why I won’t waste my money on a DNA test i... by MichaelGG on Wednesday January 01, 2014 @02:07AM (#6994457)
The FDA is _not_ trying to prevent this information. It's trying to prevent 23andme from marketing a diagnostic product that doesn't meet diagnostic regulations.

They can't have it both ways. They can market and dump out your DNA data. Or they can meet regs, prove they are clinically accurate, then market it as a diagnosis product.

We'd not like random companies starting up and misleading people and claiming to diagnose but really just flip a coin. That's all the FDA is asking.

Re:Genetics prof: Why I won’t waste my money on a DNA test i... by barry-cotter on Wednesday January 01, 2014 @03:33AM (#6994578)
The diagnostic regulations are too stringent . They are preventing people from getting information that they want to pay for, 23&me is willing to provide, and that 23&me can justify. It's not like they're taking information straight off of SNPedia, they survey the literature on the alleles of the henes they test.
Re:Genetics prof: Why I won’t waste my money on a DNA test i... by mjn on Wednesday January 01, 2014 @03:46AM (#6994597)
But they're selling things that aren't actually valid diagnostics as if they were diagnostic tests. In what sense is prohibiting that too stringent a regulation? It's not DNA-specific; if you set up a random lab that claimed to diagnose diseases from blood samples that you invite people to mail in, your lab would be shut down pretty quickly if you never validated the analyses.

If they want to sell DNA dumps and call them DNA dumps, that'd be truthful advertising. But if they want to make diagnostic claims, they need to actually back them up.

Re:Genetics prof: Why I won’t waste my money on a DNA test i... by MichaelGG on Wednesday January 01, 2014 @05:03AM (#6994685)
>It's not like they're taking information straight off of SNPedia, they survey the literature

That's the point. If they simply gave people raw results and told them to Google it, that'd be fine. They could even provide a report with hyperlinks to SNPedia. But that's not a very fun marketing message, is it? 23andme wants to sell itself as accurate diagnosis, without having to actually prove they're accurate. The FDA's letter said the FDA tried to contact them repeatedly about this issue, asked them to change language, and 23andme ignored them. What's the FDA supposed to do?

Re:Genetics prof: Why I won’t waste my money on a DNA test i... by mindcrime on Wednesday January 01, 2014 @05:42AM (#6994745)
What's the FDA supposed to do?

They should crawl back into their bureaucratic cave and carve some hieroglyphics into the walls with pieces of flint, or otherwise find some way to occupy themselves while the world goes on quite well without their unnecessary interventions.