Warfarin label change spotlights molecular diagnostics

The FDA is prepared to announce new labeling on warfarin that outlines the role that genetic tests should play in prescribing the drug, noting that dosing should be dependent on certain genetic variations. As the Wall Street Journal notes, the new label underscores the growing importance of molecular diagnostic tests. But the field is riddled with complexities, not the least of which is that the use or misuse of testing could be grounds for a lawsuit. And a number of experts note that the science is so new that it's not yet ready for labeling requirements.

- read the Wall Street Journal report (sub. req.)

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