My DNA says to do a low-fat diet and cardio.

Let's play a little game called, "guess what's wrong."


The FDA got involved.


This is a clue.

Because they said a dr needs to administer the test for them to give out health results. The validity of said results was not in question.

Like, results were showing increased risks for certain cancers/diseases and people were taking medical action based on them so the FDA said this test needs to be classified as a medical device and not distributed without a dr.'s consent.

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

However, even after these many interactions with 23andMe, 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. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

Oh, you sent a sample! Then the test is valid. And yes, there is science to backup the predisposition, it´s not crap.
The whole data thing is also true, that´s how we do it in the laboratory.

Oh, you sent a sample! Then the test is valid. And yes, there is science to backup the predisposition, it´s not crap.
The whole data thing is also true, that´s how we do it in the laboratory.

For this to be valid in the United States it has to be PROVEN TO BE SAFE AND ACCURATE! This service the OP used is NOT approved because the company has failed to prove its product is safe and accurate.

It is approved for raw DNA files and ancestry. They had to stop offering their health analysis. Which I didn't use. They still offer the rest of it. The website I used for the health information has not been shut down. Which doesn't prove it's right.

This test is safe and really accurate. Mabye the OP company hasn´t proved or garanteed that it is, I don´t know. I´m just saying that, scientifically, it´s completely proven to be accurate.