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Diagnostics Arena Changing, For Better and Worse

This morning's New York Times has an extensive article on the new wave of genomic-based diagnostic tests. The new territories they can explore in diagnostics are exhilarating, and their profit margins are far more than those for conventional tests. But concerns remain about whether the extra cost is justified, and FDA is interested in expanding its regulatory oversight. Traditionally, FDA has regulated tests sold to doctors and hospitals but not those done by a single lab.

This will have to be looked at on a case-by-case basis, though. For every genomic-based test that's nothing more than an excuse to pad profits, there will probably be several that represent real improvement, saving costs in the long run.  

 

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