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What's Next For LDTs? FDA May Be Eyeing A New Game Plan

Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.

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In light of indications from FDA that it has put on hold, if not fully abandoned, finalizing its controversial and long-awaited regulatory framework guidance on laboratory-developed tests (LDTs), industry experts say there are other approaches agency could look at to achieve the same or similar objectives.

Last week, stakeholders received a message from FDA that the LDT guidance would not be released this year. Instead, the agency says it plans to work with industry and Congress to try achieve its objective to ensure safety of LDTs, which are typically defined as tests developed and offered as a service out of the same lab

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