FDA Orders 23andMe to Halt Sales

Question

The pioneering genetic screening service 23andMe has been told by the FDA that it “must immediately discontinue” marketing of its Personal Genome Service (PGS) until it receives FDA authorization.

Read the article at:

http://blogs.wsj.com/corporate-intelligence/2013/11/25/the-letter-fda-orders-23andme-to-halt-sales/

Comments

Thanks for posting this news, Billy.

Answer 1

There is some confusion about the 23andme regulation by the FDA.

23andme is not banned from selling their DNA service, they are only banned from marketing the service. The FDA is concnerned the 23andme's marketing promises health advice that could possibly be injurious to users.

Once 23andme modifies their marketing, all will be back to normal.

Meanwhile, their genealogy service continues unaffected.

Answer 2

I tested, also.  Haven't unloaded "Raw Data", as yet; wasn't sure what supplier to use.

I was negative on breast snipets?  What now?

Maternal is:  Sowell, Reynolds, Kelly, Dean, McWilliams, Lee, etc.

Regards

Comments

I transferred two of my families kits over to FTDNA, took less than 24 hours to be up and running.  I was impressed, it said 4 weeks for processing on order page. Have found some promising leads and more exciting people have actually responded to emails!

Answer 3

Thank you for posting this. I was ready to buy one or two tests. I hope they get things straightened out with the FDA soon. I would like the clues the test provides genealogically, as well as, medically.

Comments

Glad the post is helping. It may be worth searching for alternative testing companies until this gets sorted out with the FDA.

Answer 4

Hi all,

I received the following email from 23andme.com.  I thought it might be of interest.

Dear 23andMe Customers, 

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday. 

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well. 

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you. 

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives. 

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process. 

Anne Wojcicki
Co-founder and CEO, 23andMe

Comments

Nice to know they're working on it with the FDA.

thanks for posting that

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I received the same e-mail. She doesn't explain why they have not responded to the FDA for the last 6 months.

The issue is marketing. 23andMe and its CEO are pushing the test as being able to do a lot more than it can. People who take the test need to realize the health results should be viewed with the same grain of salt as the ethnic results. They don't test all known SNPs for a condition and often only test a very small percentage. The percentages and risk factors are based only on the handful of SNPs they test and do not take into account hereditary, environmental, personal choices, and numerous other factors that can significantly raise or lower the percentages. I looked at my highest risk factor on their list. It tested 2 SNPs and used one of them to generate the percentage. In five minutes, I found a study that was 3 years newer than the one they used and it mentioned 7 genes that were very influential in getting the condition. I clicked on a link under the condition's report. I took the survey and it showed me at much lower risk for the condition. Both the survey link and 23andMe were ignoring key points. In 23andme's case, they are ignoring a minimum of 5 SNPs known to raise/lower the risk, they are ignoring the various factors mentioned above. For the survey link, they weren't taking into account any of the SNPs. Research shows 8-14% of the condition is based on genetics so 23andMe is ignoring 86-92% of the risk factors, including one that is responsible for 90% of the condition. Short of hiring a statistician or actruary expert, there is no way I would be able to determine a close approximation of my odds of getting the condition. Even with their help, 23andMe didn't test 5 or more SNPs that could dramatically alter the odds higher or lower.

They need to revamp the system and make it clearer to people who are considering testing how little they should rely on the results. Or, they should do a lot of other things to improve the results.

I appreciate what the CEO wants to do, but not the way the company is trying to do it. If she wants to give us the results she claims 23andMe can give, then she needs to spend a ton of money to do it.

The company's new chip is going to test 267,000 - 367,000 less SNPs than its current chip. That's a major downgrade. Some of the experts think it's going to be a major cut in the genealogy side of the chip, but 23andMe hasn't given details.

Answer 5

It is a shame that the US federal government thinks we are too stupid to make oiur own decisions.  The ordered shutdown of 23andme is just the latest incarnation of restricting our freedom to what "they" think we should be allowed.   I believe the FDA has overstepped it's bounds and have really streched to define the DNA testing kit as a "medical device". If the reader is a US citizen, please take a moment to sign the petition to the FDA at: https://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits# Thus far around 3500 people have signed.  The petition reads:

"To: 

Margaret Hamburg, FDA Administrator 

Reverse the ban on 23andMe's saliva home-testing kit, and focus future FDA efforts on educating doctors and patients about the benefits and limitations of genetic testing — rather than simply banning personal genomics products.

Sincerely, 
[Your name]"