Welcome to the real world: Do the conditions of FDA approval devalue high sensitivity troponin?

In January 2017 the Food and Drug Administration (FDA) approved the first high sensitivity cardiac troponin (hs-cTn) assay for use in the United States: the 5^th generation hs-cTnT assay manufactured by Roche Diagnostics. This landmark decision finally enables Americans to benefit from the same improvements in diagnostic technology that the rest of the world has utilized for some six years.

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