FDA orders local firm to stop marketing DNA tests

23andMe in violation of federal regulations with its genetic testing service

The Food and Drug Administration has ordered Mountain View-based 23andMe to immediately stop marketing its DNA sequencing kits directly to consumers.

The FDA warned 23andMe CEO Ann Wojcicki that the company is marketing its "Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act," it said in a letter dated Nov. 22.

The letter was signed by Alberto Gutierrez, director of the Office of Invitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health. Elaborating on his concerns, Gutierrez explained that he remained skeptical of the company's service.

While the Personal Genome Service is marketed as a tool to empower consumers -- by informing them of certain genetic risks and providing them with knowledge that would help them make better treatment choices -- Gutierrez wrote, "We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses. ... Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."

In a brief response to the FDA's letter, posted on 23andMe's website, the company wrote, "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."


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Posted by mari posa
a resident of Cuesta Park
on Nov 26, 2013 at 3:32 pm

It blows my mind that for so many years 23&me disingenuously and knowingly break the regulatory laws and market their tests to the uninformed public, often misleading patients who get wrong results. I have discussed this issue with a HR manager at this company a few years ago and mentioned to her the extreme importance to have their test FDA approved before they attempt to commercialize them. The FDA should not only stop 23&me, but also heavily fine this company for selling an unapproved health product that can be seriously misleading, require to reimburse the patients that have submitted samples for analysis, and shut down the company.

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Posted by regulation street
a resident of Cuesta Park
on Nov 26, 2013 at 11:52 pm

I agree with mari posa. My genome feels safer already with these crooks shut down! How dare they try to innovate in a new realm of medicine without explicit approval from government. What would we be like if other companies in the Bay Area did the same? We may as well be living in Somalia if this goes on!

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Posted by LarryR
a resident of Old Mountain View
on Nov 27, 2013 at 10:40 am

I too strongly agree with Mari Posa. And I'm amazed at the lame response 23andMe posted on their web site.

I'm ashamed they are in the Mountain View community.

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Posted by chas
a resident of Monta Loma
on Nov 27, 2013 at 11:09 am

What a bunch of Ludites. It seem that the comments posted so far are by people who favor burning books. The science of genetics is still in the early stages but certain diseases do seem to have a genetic component. I see no problem getting some information about my genome. If there was something concerning that turned up it would give me a talking point to bring up with my doctor on my next visit. But it would only be one piece of info among many.

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Posted by Greg
a resident of Cuesta Park
on Nov 27, 2013 at 2:09 pm

In other words, the FDA has decided that I'm not smart enough to be allowed to know about my own genes.

Gee, thanks.

I don't mind the FDA regulating this to make sure the information is accurate. That's not what this is. This is about the FDA deciding that I might misinterpret the data, and that therefore I should not be permitted to see it.

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Posted by mari posa
a resident of Cuesta Park
on Nov 27, 2013 at 2:18 pm

the FDA is not interested in your genes, it is interested in accurate reports that 23&me do not provide. Got it?

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Posted by Angela Hey
Mountain View Voice Blogger
on Nov 27, 2013 at 9:48 pm

Angela Hey is a registered user.

The real problem is in getting consumers to understand chance and probabilities. With a fair 6-sided dice, there's a 16.66667% chance I'll throw a 6. 23andMe is about showing people chances, not certainties.

You can look at your ancestors and see what they died from or use 23andMe. Neither will give you 100% accurate diagnoses, but that doesn't mean they have no value.

Drs are concerned with the ill. 23andMe is concerned with preventing illness, and other things like where your ancestors came from.

Sometimes far too much trust is placed in the hands of Drs. For example, I would like to walk into a clinic like Qwest Diagnostics for a blood test and read the results myself with the help of websites that interpret standard blood tests. But you need a Dr to ask for the tests. It would reduce the cost of health care, free up the Dr's precious time and give me quicker results.

See my original article on 23andMe (Web Link) - the cost of the test as of this writing is $99 - I know some states don't allow it already (e.g. New York) - but my take is Caveat Emptor (Buyer Beware).

And ensure that every 10 year old knows how to understand and compute probabilities - but that might mean less money for the State Lotteries and Las Vegas.

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Posted by SP Phil
a resident of Shoreline West
on Nov 29, 2013 at 9:11 am

Angela, I agree with you--23andme has value to people who understand probabilities and what that implies for themselves.

I was an early purchaser of a 23andme kit and reviewed the "Health Reports." I noted that several of the medical conditions that were rated "Less Likely" were in fact conditions I had already had, e.g., breast cancer.

Rather than conclude the results were "wrong," I understood that the existing state of published research on genetics and medical conditions was only evolving, that there were no firm answers yet (maybe in a decade or more?), and that the results were "interesting" nonetheless.

I find the genealogical component the most interesting, and that is why I bought a kit in the first place.

The level of genome analysis 23andme can provide for genealogical purposes is nothing short of amazing. The specific links to quite distant relatives (4 generations back and more) have been fascinating, but moreover it demonstrates how interconnected we ALL are.

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