Companion Drug/Diagnostic Pathway: A Question of Where and Who

FDA has put a lot of thought into preparing for the drug/diagnostic companion products that presage the era of personalized medicine; but the lure of fewer controls and less development costs is tugging some of the effort off-shore. FDA is also scaring off small companies from genomic test projects and their VC investors. Is this really an opportunity that is slipping away from the US or just an opportunity only for some participants?