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I think the issue is that 23andme has no rigorous data on what the false positive and negative rates are. Unless they can supply that it's snake oil. And I say that as a 23andme customer.

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23andme has always been regulated as a clinical laboratory, the same as any other genetic testing laboratory. What's different with 23andme is that besides just telling you that you have a certain BRCA mutation, 23andme goes on to say that based on current research that suggests you might have a higher risk of breast cancer. It's that later part which the FDA says pushes 23andme from being a genetics lab to being a medical device.

Why did you use such a dangerous product?

Unless the kit includes a self-mastectomy tool, I don't think the FDA should get hysterical.

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