How Will the FDA Impact the Laboratory Developed Test?

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How skilled are you at completing a Food and Drug Administration (FDA) pre-market approval or 510-K application? If your laboratory has developed tests in-house (also known as “home brew” and now termed laboratory developed tests or LDTs) and changes proposed in Washington actually occur, these terms may become part of our everyday vocabulary.

The FDA currently regulates most LDTs, through the reagents used, by the Analyte Specific Reagent (ASR) rule. This rule requires the laboratory using the reagent to perform its own method validation and include a comment in the test report that FDA approval is not required. However, given the rapid growth of gene and protein-based tests, some say additional regulation is needed to protect the public.

Last fall the FDA issued draft guidance stating it will require FDA premarket approval for in vitro diagnostic multivariate assays (IVDMIA). These assays pair a laboratory test with software or an algorithm that produces a result specific for the patient in question. Unfortunately, the performing laboratory cannot completely validate the test method, and the ordering physician cannot interpret results, without access to proprietary information. The FDA believes these test systems exceed ASRs and warrant further regulation because the novel technologies have a risk of lethal outcomes.

Two bills have also been introduced in Congress that mandate additional regulation of LDTs. First, the “Laboratory Test Improvement Act” (S.736) is sponsored by Edward Kennedy (D-MA) and Gordon Smith (R-OR). It would classify most LDTs as Class II medical devices and some as Class III.