Regulatory Conference Discusses Oversight of Laboratory Developed Tests

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Regulatory conference highlights need for defined governance of laboratory developed diagnostic testing.

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Federal agencies need to establish a consistent framework to regulate laboratory developed tests (LDTs), according to speakers at a conference of the Regulatory Affairs Professionals Society (RAPS), a global organization focused on healthcare product oversight.

According to Barry Sall, Principal Consultant for PAREXEL Consulting, insufficient agency oversight of LDTs has resulted in ambiguous direction and guidelines for manufacturers as well as inadequate federal assurance for patients.

In an effort to streamline oversight, the Coalition of 21st Century Medicine, an organization composed of researchers, physicians and advocacy groups, created a plan for redefining LDTs and creating a new structure for Food and Drug Administration  (FDA) regulation. Currently, the FDA regulates LDTs as medical devices while the Centers for Medicare and Medicaid Services (CMS) regulates the laboratories themselves. The Coalition’s plan, as presented at the conference by Dr. Liz Horn of Genetic Alliance, a genetic advocacy organization, will place LDTs within a new category of Advanced Personalized Diagnostics (APDx) to be governed solely by the FDA.

According to the proposal, a new FDA office would regulate APDx according to the impact of the diagnostic results. High impact tests will receive greater regulatory scrutiny. The plan would eliminate ambiguity and conflict between FDA and CMS regulation by assigning all oversight responsibilities to the newly created FDA office.

This plan stands in contrast to the Modernizing Laboratory Test Standards for Patients Act recently proposed by Rep. Michael C. Burgess (R-TX). This legislation would establish pre-market and supplemental approval protocols for LDTs and would assign regulatory authority to CMS.

Representatives from the FDA and CMS chose not to comment publicly on the proposed plan at the RAPS session. It remains unclear how either will proceed or whether legislation will direct future LDT regulation.