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Laboratory-Developed Test Oversight

Background

CAP Advocacy promotes a favorable, effective regulatory environment through its engagement with the Congress, Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and other industry groups for a sensible public-private oversight to ensure the quality and accuracy of laboratory-developed tests (LDTs).

With Congress pursuing the enactment of an LDT oversight plan, the CAP advocates to protect patients and to provide access to safe diagnostic tests with a framework that is the least burdensome for laboratories. Any extraneous provisions included in legislation interfere with the goals of ensuring access and quality tests for patients.

Additional Information