Can someone summarise why the FDA have any say in genetic testing? It's not as if they are selling a drug or other substance that might be incorrectly made or labelled. Presumably spitting into a vial can't cause harm.
[23andMe] ... edged closer and closer to marketing their services as a way of predicting and even preventing health problems. And any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is, according to federal law, a "medical device" that needs to be deemed safe and effective by the FDA.
Providing incorrect or misleading information could lead to people making health decisions with potentially serious consequences. If that information is wrong people could take unnecessary risks with their health.
I hope 23andme is shutdown.
My understanding is they sequence some of your dna, and then link to various publicly available studies to show users "This paper showed this mutation correlates with this disease".
Is that not a correct description of their service? Why do you want them shut down?
The absolute vast majority of people will die from heart disease or cancer. What is the point of paying money to find that out?
Obviously there's also the privacy aspect as well - trusting your DNA to some private company who wants to make profit.
If you have a symptom, or family history of some disease, go see a doctor. That's kinda what they're there for. And they train for years in order that they can interpret results correctly.
"Patients relying on such tests may begin to self-manage their treatment through dose changes or even abandon certain therapies depending on the outcome of the assessment," he added.