And Now a Suit

A class action lawsuit has been brought against 23andMe after the company received a letter from the US Food and Drug Administration.

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Here we go. "when there is no

Here we go. "when there is no analytical or clinical validation for the PGS". There are for some of the pieces of information provided, but don't let specifics get in the way.

Again, lack of education and here, forget 23andMe. We need to educate the public regarding genomics and healthcare providers on what is legitimate and what is not.

Not to defend 23andMe per se,

Not to defend 23andMe per se, but it will be fascinating to hear what $5 million in harm was done to her by getting her profile. It's a shame that frivolous lawsuits are a cost of doing business.

No argument about the concept

No argument about the concept of educating the public. The larger picture, however, is that the public's capacity for actually comprehending complex topics, such as applied genomics, genopharmacology, and related arenas of development may be more limited than what would be a realistic match for such expectations.

An educated populace is required for making sound decisions, but an educated populace is also a very tall order, compared with the complexities already at hand which shape regulatory (and by implication, political) policy.

No political correctness here . . . just expressing the reality of the moment. At some future point, access to health care (and other life structuring mechanisms) will be filtered and modulated by genetic content.

Another gift to the Trial

Another gift to the Trial Lawyers of America from the FDA, EPA etc. And the band played on...

I agree educating the public

I agree educating the public would go a very long way, at $99 23andMe isn't providing a diagnostic tool, rather give you an understanding whether you have the gene or not, and a soft percentage metric of likelyhood of disease. In cases of adoption, this could provide just some great 'insight' as that is all that it was meant to be. After the FDA and lawsuits are done with 23andMe, it won't be within financial reach for most, and be only available to those than can afford it, what a shame.

To me, the major issue is

To me, the major issue is that 23andMe has failed to validate its PGS gene chip.
".. we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests." Those knowledgeable scientists who use micro-arrays for SNP genotyping are all to aware of the shortcomings. It's unfortunate that 23andMe chooses not to undertake validation studies to show that the results are not providing false positives and false negatives. Or, if they are, the root causes and corrective actions they plan to take.

Inexpensive service like

Inexpensive service like 23andMe will stimulate folks to bug their doctors. They stimulate the general public to get education, from any of the articles one may read that are linked to the documents, and other resources. If they have questions, most folks can bug their doctors, and get a more valid test for a specific condition if warranted. It would be great if the media, and government agencies did a better job of education in this area, rather than restricting access to information. Just saying…

Ah! The precautionary

Ah! The precautionary principle of the FDA is being trumped by the precautionary principle of the 23andme customers who are willing to learn a little about what risks they might be able to mitigate. One might think that FDA will lose this little gambit. People have a right to learn about themselves. FDA will consider that maybe they should reexamine their own risks.

Ah! The precautionary

Ah! The precautionary principle of the FDA is being trumped by the precautionary principle of the 23andme customers who are willing to learn a little about what risks they might be able to mitigate. One might think that FDA will lose this little gambit. People have a right to learn about themselves. FDA will consider that maybe they should reexamine their own risks.

Frivolous lawsuits are so

Frivolous lawsuits are so evil! When I get that class action notice I'll be tempted to ship it back with a goat's head. (j.k.) As a 23andMe customer, I think they've done a pretty decent job of explaining the basic science and the uncertainties of trying to predict disease risk given only genetic information. They also make customers click through two layers of "Yes, I know this isn't going to tell me whether I'll get sick or not but I'd like to see it anyway" before showing sensitive info like BRCA variant calls. At this point, I think 23andMe is unlikely to hold many medical surprises for someone who knows their family medical history, especially if they're 35 or older. 23andMe could say more about the error rate of the underlying technology, though.

I agree with Michael Eisen's views regarding the 23andMe FDA letter: http://www.michaeleisen.org/blog/?p=1480

I have used the 23andme

I have used the 23andme service and am impressed by what they have achieved. This lawsuit is complete nonsense.
We need to support this young industry, and our own freedom to get genotyping services.

I applaud FDA oversight and

I applaud FDA oversight and want them to continue in their efforts to protect the general public as best they can. I really, really don't like pre-data marketing and the public interest in genetic medicine should not be manipulated like a guinea pig.

Drug companies are frequently

Drug companies are frequently and heavily slammed by the FDA for making unsubstantiated claims of medical utility. How is this test any different? The FDA required 23andMe, in writing, to provide data in support of their claims, but they apparently decided to market their product's claims without doing so. If they were a drug company, they might be facing a very large fine, and not just a cease and desist notice.

I am a 23andme customer since

I am a 23andme customer since 2008; I have my own family of 6 tested. The information provided by 23andme is decent and improved significantly through the years. As a scientist, I use 23andme data to learn my own genetics and my family, I support 23andme. But I also think the validation of assay is necessary, especially for those SNPs that have significant health impact. It will be challenge for 23andme to keep the test affordable to general public.

"Needing an education" should

"Needing an education" should not be a requirement for being genotyped any more than it should be a requirement for looking at yourself in a mirror. 23andMe may have overstated some of the benefits, but you probably cannot overstate the self-education you can get by being genotyped and then using the 23andMe site.

"An educated populace is required for making sound decisions, but an educated populace is also a very tall order, compared with the complexities already at hand which shape regulatory (and by implication, political) policy."

Could not agree more!

Could not agree more!

Was an early customer of

Was an early customer of 23andMe; has been a wonderful "journey" to get constant updates as new data is available. My daughter has now submitted a sample, as well as a friend. The information that we are getting makes sense, given our history! I've also been connected to distant relatives through the ancestry links. The criticisms from FDA are heavy handed; someone "might" go through extensive treatments because of a result from this site is absurd! It only opens up the site to these kinds of frivolous lawsuits, and may ruin this for all of us. Hope not, and will fight alongside 23andMe to keep this service low cost and available to the masses.

Lets get past this faux

Lets get past this faux democratic nonsense that everyone has the right to their own genetic information! Of course they do but dont pull a bait and switch. 23andME doesn't offer you your raw data alone, they offer an interpretation of that data. By doing so they are required by consumer protection laws to show its accurate. Period. We should ask the same of all consumer oriented companies.

They cant have it both ways by heavily marketing medical claims for their service with their fingers crossed behind their back as they place disclaimers in the fine print.