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MJS

I'm an informed customer of 23andme, with some knowledge of statistics and in interest in learning more about genetics. I'm disappointed in the FDA decision and your response.

If you are an "unsuspecting customer" using only 23andme results to drive your healthcare decisions, then you will always be an "unsuspecting customer" regardless of the health product you consume. Removing 23andme from the market removes benefits to some while eliminating risk to individuals who are at risk for poor decisions regardless of what data they are based on.

If you are unaware, 23andme also has a genealogical component that I, as an adopted person, find extremely interesting. Shutting down 23andme dramatically reduces my opportunities to learn more about my biological heritage.

In my opinion it is better to start on the creation of a large scale database with the opportunity to improve test quality and reliability on-going than to wait for a perfect system. Additionally, I have some experience with what is required for FDA compliance and let me say that being in compliance does not necessarily equal providing a useful product or service.

Chris P

I have been in the pharma/medical device industry for 20 years now and know some of the stories in the pathology/testing world from colleagues.

Technology innovators came up with a cool information-based product and sold it at first as a novelty. FDA was fine with the "for entertainment purposes only" nature of the information provided. Entrepreneurs enhanced their product in the last year to provide data that was truly diagnostic or related to therapeutic guidance (BRCA1, CYP processing) and started pushing this information out. FDA was not pleased with the validation studies that had been done on that information and said it needed to hit 510k qualifications. Management had an experienced Reg Affairs Director (from xDx who faced similar challenges ?) but decided to play tough. Why play tough? My speculation would be that the validation testing would swamp the company or they thought they were too big/popular/cutting edge for the FDA to stop them. Having worked at a company with multiple letters from the FDA that ended with a consent decree stopping sales for 1.5 years, I would say the popularity card does not work. If the FDA perceives the risk to patient safety, it is up to the company to PROVE it is safe rather than for the FDA to show evidence of the harm done. I am curious to see how the next chapter reveals itself.

I would agree that they were providing a useful service, but we don't know that it is consistent and at the quality levels necessary.

In this, the CEO points out that they were using a non-CLIA lab for the tests initially. I read that as management not reading the regulatory environment well from the beginning.
http://www.fastcompany.com/3022224/innovation-agents/why-23andme-terrifies-health-insurance-companies

Dina Felice

I am extremely disappointed to hear that the FDA decided to take away an optional service for individuals. As someone with a Master's degree in Human Genetics, I chose to have this testing to enhance my knowledge of my own genome, fully mindful of the limitations.

I learned that I am likely sensitive to Warfarin, a potentially serious health risk when you are unaware of your sensitivity. Now, I already knew I had a family history of this, but prior to taking this test, it never would have occured to me to mention it to a doctor. Now, I am much more likely to let a doctor know about this potential hazard.

I also learned that I am not a carrier for the Tay-Sachs gene. This is relieving to know, even though I would never trust these results as the final word on my carrier-status. I still fully intend to have a full Ashkenazi Jewish genetics panel done by a certified lab and with results evaluated by a physician prior to having children. In the meantime, this is something nice to know.

I find it extremely obnoxious that both you and the FDA have decided I need to be 'protected' from knowledge (however flawed) I chose to seek out for myself. I am not a child and I do not appreciate being treated as one. If the FDA doesn't have enough to do, I would suggest looking into the vitamins and supplements which can have any crazy claims on their labels (that, in fact, do not even have to have the ingredients listed on their label). That can ACTUALLY harm people's health. Leave my voluntary decisions alone.

Kevin Henry

Please think about the message you send when you refer to a successful female entrepreneur only by reference to her husband. (For the record, Ms. Sergei Brin's name is Anne Wojcicki.) And why are you linking to "news" of their separation? Who cares?

Kaiser

MJS and Dina: FDA's job is to protect the average citizen. The fact that some people think a product is useful does not substitute for proper testing and certification. 23andme can submit proper documents to get approval, and they chose not to do so.
MJS: 23andme should market the genealogical component as a separate product; I disagree that a bad product should be sold because it is bundled with a good product.
Also, the fact that some approved drugs are bad does not mean that all approved drugs are bad.
Dina: By your logic, all experimental drugs should be made legal since it is always true that some individual will benefit from it. Overtreatment and side effects kill people.
I do agree that "vitamins and supplements" should be regulated but that has nothing to do with 23andme.

Ken

This reminds me of something that was happening in the UK. People could go to a third-world country and have a complete set of diagnostic tests done fairly cheaply. That included things like a whole-body CAT scan. The problem was the at times it would find things that may have been evidence of disease. An example is of something that was possibly a small tumour in the brain. The problem is that brain surgery is very risky so no one is going to do anything about it unless their are other symptoms. Possible outcome is that they will see a lot of doctors trying to get something done about something that is better left alone.

Kaiser

Here is a good read on the subject.
It's clear they do not report any error bars, which are gigantic by the nature of what they are doing. You can't interpret something like a 5% higher risk than the "average" unless you know which "average" they are talking about and the error bar of the estimate.

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