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Assessing the Clinical Service & Revenue Issues of the LDT Rule

Clinical labs must understand cost-benefits of their LDT offerings as they prepare for FDA compliance

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical laboratories will have to comply with the U.S. Food and Drug Administration’s (FDA) new final rule regarding laboratory developed tests (LDTs). To do so, many laboratories will need to take a hard look at their current LDT offerings, with an eye toward which ones are …

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