Liquid Biopsy Technology: FDA's Latest Guidance Supports ... - Cooley
The FDA's draft guidance on ctDNA for early-stage solid tumor drug development outlines its use as a biomarker in clinical trials for patient selection, enrichment, response measurement, and as an early endpoint. It emphasizes the importance of assay validation and encourages sponsors to consult the FDA for regulatory uses of ctDNA.
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Liquid Biopsy Technology: FDA's Latest Guidance Supports ... - Cooley
The FDA's draft guidance on ctDNA for early-stage solid tumor drug development outlines its use as a biomarker in clinical trials for patient selection, enrichment, response measurement, and as an early endpoint. It emphasizes the importance of assay validation and encourages sponsors to consult the FDA for regulatory uses of ctDNA.