This is what you now see when you visit 23andMe’s site:
23andMe sells (rather, used to sell until the FDA told them to stop) a $99 test kit that tells you your risk for over a hundred diseases by having you mail back your saliva and comparing its DNA with other people’s DNA.
The test was never validated for that use, so the FDA, after years of working with 23andMe, told them they “must immediately discontinue marketing the PGS [personal genome service] until such time as it receives FDA marketing authorization.”
I have read comments from people defending 23andMe, saying the test is valid, implying that the health risks it returns are accurate, generalizable to diverse populations, and actionable. The FDA says otherwise, that the test has not been validated (“we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses”.)
Is 23andMe selling an insufficiently tested, unvalidated product to an unsuspecting public? Yes, they are. Or, they were.
A medical device should be sufficiently validated for its use in assessing risk before it is used as justification for any additional test, any surgery or other intervention, any further expense – to prevent doing more harm1 than good. Health risks associated with a DNA analysis should be communicated by a team of healthcare professionals.
Speaking of harm … See that “I Understand” button at the bottom of their splash screen? Is that here to protect the consumer?