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# Circulating Tumor DNA Use Guidance
- URL: https://www.fdaweb.com/circulating-tumor-dna-use-guidance/
- Published: 2024-11-27T12:00:00.000Z
- Updated: 2026-09-14T14:48:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158270

FDA has published a guidance, *Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development*, to help sponsors planning to use circulating cell-free plasma-derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an IND and/or to support marketing approval for drugs and biological products for treating solid tumor malignancies in the early-stage setting. The [document](https://www.fda.gov/media/183874/download?ref=fdaweb.com) also discusses the standardization and harmonization of ctDNA assays and methodologies, with a particular focus on assay consideration to assess for molecular residual disease.

The guidance does not address using ctDNA for the early detection of cancer or cancer screening, FDA says. It also does not address using ctDNA in the metastatic cancer setting, although it says that some principles may apply across multiple disease settings.