FDA orders genetic testing firm 23andMe to halt sales

[Blackking]

The Food and Drug Administration has ordered genetic testing firm 23andMe to stop sales of its home-testing kits, saying the Google-backed company has failed to prove the validity of its product.
23andMe is led by Anne Wojicki, who co-founded the company in 2006 and recently separated from her husband, Google co-founder Sergey Brin. Google (GOOG, Fortune 500) has invested millions of dollars in the company in recent years.


23andMe offers $99 saliva-testing kits that customers use at home and then send to the company for reports on their heritage, their receptiveness to medications and their genetic risk for dozens of health conditions.

"Strike back before cancer has a chance to strike," the California-based company says on its website.

But in a letter dated Friday and posted on its website, the FDA said that despite extensive correspondence with 23andMe, regulators "still do not have any assurance that the firm has analytically or clinically validated the [personal genome service] for its intended uses."

Related: The race to a $100 genome

The agency warned of the potential health consequences for customers whose results contain inaccurate positive results for health risks. Women whose results indicate a risk for breast cancer, for example, could undergo unnecessary surgery or chemotherapy.

The FDA said 23andMe "must immediately discontinue marketing the [personal genome service] until such time as it receives FDA marketing authorization."

23andMe said it "recognize that we have not met the FDA's expectations regarding timeline and communication."

"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," the company said in a statement.

Wojicki has claimed that 23andMe has already mapped the genotypes of nearly 500,000 people. The company's name is a reference to the 23 chromosome pairs present in human cells.

FDA spokeswoman Erica Jefferson said the agency "supports innovative products that can be demonstrated to work as claimed."

"The FDA has worked and will continue to work closely with any company marketing direct-to-consumer genetic tests without stifling innovation," she said.

http://money.cnn.com/2013/11/25/technology/fda-23andme/index.html

 

[88m3]

this will be interesting

 

[Serious]

I was always iffy about supporting this company, I remember I signed up a for a free kit, but ultimately refused to send it in...

in before @DEAD7 , the FDA blocks the invisible hand again...

 

[88m3]

@theworldismine13

 

[Hiphoplives4eva]

Sent in my free kit already. I hope i dont lose out on my reading because of this. I'm sure the FDA stepped in once this "African DNA project" became official.

Cacs being cacs....

 

[Mr. Somebody]

Is the FDA hating?

 

[theworldismine13]

There are two sides to the 23andme testing, one part is the ancestry testing and the other part is a health risk assessment

I would have to agree with the FDA concerns, 23andme are making predictions and it isn't clear what the science behind their predictions is, it doesn't mean it's false it's just not clear, and they are essentially giving medical advice but a geneticist is not a doctor

But anyways this issue is seperate from the ancestry part of the site, the ancestry side is straightforward in terms of science

 

[OneManGang]

I'm ok with this. The ramifications of a faulty test are huge. Prove your methods and their validity.

Edit: @theworldismine13 beat me to it and said it much more clearly

 

[NZA]

family history stuff: fine
disease risk factor percentages: way too ahead of science to be scaring people with the stuff.

unfortunately for them, as a business venture, they need all the value adds they can get to increase sales. that disease stuff was probably a huge growth potential.

 

[bigDeeOT]

Kind of makes you appreciate the fact that we have government regulations checking into this kind of stuff.

 

[Self_Born7]

you mean the same FDA who said, its okay and healthy to eat GMO foods? even though countless countries around the world ban GMO food and have been proven studies, that shyt is a major health risk.

 

[bigDeeOT]

you mean the same FDA who said, its okay and healthy to eat GMO foods? even though countless countries around the world ban GMO food and have been proven studies, that shyt is a major health risk.

Ughhhh actually no. There is NO consensus among the scientific community that GMOs are bad. I don't think you've done an objective research on the issue.

 

[Everythingg]

So they got an ancestry test? Has anyone tried it?

 

[Self_Born7]

Ughhhh actually no. There is NO consensus among the scientific community that GMOs are bad. I don't think you've done an objective research on the issue.

if GMO's are so good and healthy for us , then why is Montasano spending millions to keep their gmo products not being labeled? Do you trust you food being made by the worlds largest pesticide company? It must be enough consensus if there are 26 countries that have banned GMOs.

 

[bigDeeOT]

if GMO's are so good and healthy for us , then why is Montasano spending millions to keep their gmo products not being labeled?

Because people are sheep that's why. It's not for education purposes, its just to create a stigma. It will be used to mislead consumers into thinking their is something harmful with the food.

I agree there is something wrong with the company montasano. In fact if you google up the debate over GMO's, you will find their name mentioned a lot with a lot of hate for them. But that doesn't change the fact that there is no consensus in the scientific community over these so called harmful effects of GMOs.

Second, all foods have been genetically modified for hundreds of years now by artificial selective breeding. They selected for traits by only breeding with those of desirable traits. Thus, getting rid of genes undesirable so that is the same thing as a genetically-modified-organism.

Now, we can select for desirable genes in the lab. And we can transfer a gene from one organism to another. They are not artificially creating unique gene sequences. The protein encoded from these genes are already found in nature! They just transfer it from one species of plant to another species of plant.