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Laboratory-Developed Test Oversight

Background

The CAP 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 regarding the oversight 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.

Since 2009, the CAP has advocated for a regulatory framework that enhances patient safety, maintains quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists. In 2015, the CAP proposed a legislative framework for LDT oversight that used a stratified approach to effectively balance regulation by the FDA and CMS without stifling innovation or patient access to LDTs. The proposal focused FDA oversight on the tests that currently have the least transparency and highest potential patient risk. The CAP’s proposal employed a three-tiered, stratified model that authorizes a role for third party accreditors and classifies tests based on their overall complexity and potential risk to patients based upon three categories: low, moderate, or high risk. In addition, analytic and clinical validation of LDTs would have a key role in any future LDT regulation.

Additional Information