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Read the letter from the FDA. That's not what they're doing at all. They're requiring a company that sells a direct-to-consumer medical test to certify the sa
by timr 13y ago
Read the letter from the FDA. That's not what they're doing at all. They're requiring a company that sells a direct-to-consumer medical test to certify the safety and validity of that test. I don't think anyone is concerned that they're cross-contaminating their samples or working in a filthy lab over at 23andMe -- they're concerned that the whole design of the test is broken.
Again, most of this stuff is sketchy science. You can do the microarray experiments in a proper (e.g. "CLIA certified") lab, and still have a useless, dangerously misleading test.