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Saturday, August 02, 2014 6:01:46 PM
IMO this excludes AMBS in almost every way.
Quote from the article:
In its announcement, the agency tried to address such concerns, saying it would phase in the requirements over nine years and would focus oversight on the tests where a wrong result would pose the highest level of risk to patients. It would exempt tests for which there is no approved alternative and tests for rare diseases, which might be expensive to develop if required to go through F.D.A. review.
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