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Regulatory Delays Are Keeping the Diagnostics Industry in Limbo

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An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year.

Elizabeth Mansfield, director of personalized medicine at the FDA’s Center for Devices and Radiological Health, was a panelist at the Clinical Laboratory Association’s annual meeting in March during which she said that additional reviews are required before the final guidance can be issued.

At the same meeting, Marc Hartstein from Centers for Medicare & Medicaid Services (CMS) said that CMS would not meet its deadline to provide a rule about how it will “collect market data and set new rates for Medicare payment of clinical labs.”

These delays affect the two most critical aspects of the IVD industry: LDT regulation and reimbursement. The lingering ambiguity in these areas is a huge drag on investment in new tests, so hopefully resolution is at-hand.