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Future Of LDT Oversight Still Uncertain

After years of back-and-forth on the issue, the debate over which federal agency will regulate laboratory-developed tests (LDT) going forward is far from settled. The FDA says it has the statutory authority to regulate LDTs and will release a final guidance on LDT oversight this year. Meanwhile, some lawmakers and industry groups are circulating alternative proposals that would either give FDA more authority over LDTs or give the authority to CMS under an expanded CLIA program.