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Sccrbrg

08/02/14 6:01 PM

#106829 RE: Solantey #106827

This is practically a non-issue for AMBS at this point. Its going to be phased in for 9 years, and initially only be focused at diagnosing critical illnesses - and excludes placing regulations on tests where there is no alternative testing method.

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.

JPetroInc

08/02/14 7:30 PM

#106831 RE: Solantey #106827

FDA says "It would exempt tests with no approved alternative + tests for rare diseases"