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This article has been updated from an earlier version to correctly reflect the scope of a 2010 report cited by Sen. Lamar Alexander during the hearing that estimated the cost of FDA approval and clearance for medical devices.


NEW YORK (GenomeWeb) – As senators on the Committee on Health, Education, Labor, & Pensions mull legislative solutions to regulate lab-developed tests (LDTs) they have to try to advance a framework that facilitates rapid access to tests while ensuring patients can rely on the results.

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