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# Guide on Biomarker for Hematologic Malignancy Drugs
- URL: https://www.fdaweb.com/guide-on-biomarker-for-hematologic-malignancy-drugs/
- Published: 2020-01-24T12:00:00.000Z
- Updated: 2026-09-14T15:59:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145920

FDA has released a [final guidance](https://www.fda.gov/media/134605/download?ref=fdaweb.com) on “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials or to support drug and biologic approvals for treating specific hematologic malignancies.

“The use of MRD as a biomarker in drug development is distinct from FDA’s requirement for investigating, clearing, or approving an in vitro diagnostic device for clinical use in measuring MRD,” the guidance says. Manufacturers interested in developing a specific MRD assay for clinical use should consult with CDRH’s Office of In Vitro Diagnostics and Radiological Health, it adds.