Yeah! 23&Me knew very well that was operating under the table, performing and releasing results with methodologies which were not validated or approved by the FDA, and possibly erroneous and medically misleading. All professional companies know very well the rules of the industry and this company totally and bluntly operated illegally and unprofessionally with full knowledge of the rules.
I am glad to hear that there is a class action suit ongoing; 23&me needs to take responsibility for its actions and compensate accordingly all the past users.

For people who understand probabilities, the information from 23andme is not misleading.

My extended family, including two MDs, has purchased four kits over the years, with the understanding that the health-related information provided is based on very early research studies and only aims to indicate relative probability of being affected by a particular condition. In addition, I have a cousin who is a geneticist and has written popular books on the subject of genes and evolution--he got a 23andme kit.

Anyone who thinks that 23andme results are a substitute for medical exams and testing and and who thinks that any findings based on genetics are 100% accurate probably should not be "allowed" to buy a kit in the first place.

The rest of us find the information interesting and look forward to further research in the field.

SP Phil (who also was an early participant in the National Geographic Genome Project)

There is a difference in finding the information interesting and being accurate. As scientist, I know very well by experience that it is extremely dangerous to release medical information based in tests that are not validated. Simply, it is not acceptable and they have high probability of rendering misleading or inaccurate results.

This is awesome. Take that 23&Me. Now we just need to be rid of google. YES! I'm dancing in my apartment right now. I LOVE the FDA!

Tough call. I'm a proponent of having more information. I got a 23&Me kit and was pleased with the information it provided. I would never make medical decisions on the basis of their tests without getting follow-ups from actually doctors. Anyone who would is a fool.

Is the issue in how they market themselves? Don't they state that up front the testing is for informational purposes only and should not be taken as a substitute for genuine medical testing? Or is the problem that their tests are not actually trustworthy (which would surprise me, given the founders)?

The great scientific and medical benefit of a company like 23&Me is that it facilitates the rapid collection of a vast amount of data on a lot of people--IF their results are accurate and dependable.

You think the class action lawsuit was already filled out and waiting 'Lisa Casey' to click the send button? Just like most of biotech now, let the lawyers and trolls begin the feeding frenzy.

And no, not enough repeats in the Illumina test to make valid data.

Mari posa wrote: "it is extremely dangerous to release medical information based in tests that are not validated."

What are some examples of this "extreme danger"? A friend and I were discussing this and could only think of, for example, some people killing themselves because they thought they were at high risk of some dread condition. Are there other examples? Since provision of medical treatment is still strictly controlled by doctors and hospital gatekeepers, what is the concern? (I really want to know.)

Part of my sang froid about the 23andme results is that (1) MDs are often quite vague about their own diagnoses based on accepted medical tests. ("It may be cancer, but maybe not," for example.) And (2) I take the 23andme comments with even less conviction.

SP Phil, please do not waste time arguing with mariposa, there's clearly no data to justify -- only prejudice, possibly jealousy.. Read "Grrrreat!'s" comments, seems like he's a Microsoft or Apple employee, but then I heard even those companies hire smart people.... Hmmmm.

For those wondering what the issues are/may be, here is a video entitled "23andme vs FDA in less than four minutes" Web Link

I am not involved with 23andme (except I have a kit) nor with the video. I do have a background in statistics and I do consult a physician re medical issues. I found the above video very interesting and clear as far as the issues involved.

There are always at least two camps.... people who want to know, people who don't, then there are the curious. But after living enough life to get second opinions and maybe third opinions.... more information gives ME a place to focus. What about when depression is diagnosed for a woman? It happens all the time instead of a medical cause being found. Pregnancy tests can be wrong. So can a bunch of others.
People are complicated. Learn more, be smart.

Stop being whiny babies, and take some responsibility for your own health.

(I now live on Franklin St in downtown Mountain View - what neighborhood is that?)

The FDA letter as published did reasonably demand more compliance with the regulations than 23andme has apparently taken.

But the letter went much further. It said that people should not have direct access to their personal genetic information at all. The grounds could deny people access to common fever thermometers or glucose meters purchased outright. It could also deny people access to drug data bases and almost any other medical information.

Long Term Care insurance providers have complained that if people have access to genetic information they don't (eg, Alzheimer's susceptibility), it breaks their business model. That will be true for medical insurance in general, especially pre-ACA. Opposition to 23andme can buy or sell Washington most of the time. Slipping in opposition to consumers ever knowing genetic information is suspect and protesting isn't irrational or cranky based on the record.

Medical care is supposed to become increasingly individualized based on one's genome. Cutting people out of that completely will eventually leave us completely ignorant and helpless in many ways. Perfect consumers, really..
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From another BB - On December 01, 2013, at 8:50 AM, DickHamilton wrote:
Health insurance which is fully personalized isn't insurance at all - there is no sharing of risk, which is the only thing that makes health insurance (or fire insurance, or life insurance, or...) affordable. You deserve to have your own genetic information, and insurance companies should have access to aggregated genetic information so that they can better assess risk - but they should NOT have access to individual records - that would break the whole idea of 'insurance'.
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Single Payer insurance and a mixed, mostly independent, medical care system like we have now but more efficient may be the only way to go given genetic-based medical care at all. Insurance companies and some medical people will lobby and fight bitterly to forbid consumers from having the information that they will need. Consumers must fight back. The special interests will tend to use moral arguments, this being California. Nonsense. As usual, follow the money.......

ps - While the class action suit may be just another vulture suit entrepreneurial venture, it would still be interesting to check the plaintiff or the law firm for insurance company ties.