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.
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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.