Laboratory Developed Tests (LDTs) Face Uncertain Future

FDA’s new rule creates a dramatic change from the previous regulation of LDTs, which was frequently through the CLIA (Clinical Laboratory Improvement Amendments) process which is overseen by CMS (Centers for Medicare & Medicaid Services). CMS’ process is more focused on meeting clinical laboratory standards rather than FDAs regulatory standards.

The new regulation for LDTs is not only lengthy, it provides numerous exceptions and a four year period over which FDA will phase out their previous approach to regulating LDTs.  These changes create business uncertainty for companies which operate labs performing LDTs, drug developers who rely upon LDTs for identifying (potential) patients for therapy or changes in dosing, and related businesses mapping their future go to market strategies.

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