The FDA announced today new regulations planned for laboratory prepared cancer tests.
That will do in Gartner's attempt to sell his lung cancer test. That test will never be FDA approved and the FDA mentioned needing PMA's. That takes years.
Again, Gartner's website will never surface again.
FDA To Regulate Thousands Of Cancer, Genetic, And Other Diagnostics
The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye.
More than 11,000 of these tests, known as laboratory-developed tests, created by 2,000 different laboratories, could be included in the new regulatory framework, according to the FDA.
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