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Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility

Laboratory groups, who are facing the prospect of a new regulatory scheme in FDA’s proposed lab-developed test framework, intend to discuss barriers to test accessibility and clinical validation of LDTs in future comments.

Clinical laboratory groups plan to focus their comments on FDA’s proposed regulatory framework for laboratory developed tests on the barriers to test access they say the new scheme will create.

Representatives of some lab groups told “The Gray Sheet” in early August that they have already started to address FDA’s...

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