Variation in AML Residual Disease Testing Prompts Push for Standardization

Multiparametric flow cytometry offers a widely available, rapid method for detecting a single leukemic cell among thousands of normal cells after treatment, but its performance can vary across laboratories. New findings highlight substantial variability in MRD results, underscoring the need to standardize testing to support consistent clinical decisions.

Virginia Tech’s Fralin Biomedical Research Institute’s Cancer Research Center in Washington, D.C., led an analysis of multiparametric flow cytometry for MRD in AML. The method identifies residual leukemia by assessing combinations of cell-surface features, enabling clinicians to monitor disease kinetics and estimate relapse risk. Although the assay is broadly accessible and cost-effective, the team emphasized that interpretation can be challenging in routine clinical practice without consistent methodologies and thresholds.

Working with the Center for International Blood and Marrow Transplant Research (CIBMTR), investigators reviewed real-world data from 2,542 patients treated at 131 U.S. testing centers who underwent allogeneic blood-forming stem cell transplantation between 2013 and 2019. The analysis examined overall survival, non-AML mortality, disease-free survival, and relapse. The study was published in Haematologica.

Results showed substantial variation across centers in how well pre-transplant MRD testing by flow cytometry predicted outcomes. Although patients who tested positive were more likely to relapse, most relapses occurred in the larger group that tested negative, highlighting the need for greater sensitivity and harmonized interpretation. The team noted that existing guidance leaves compliance to individual sites, with U.S. testing remaining largely decentralized.

To improve consistency, a planned task force will define the supporting data and safeguards needed for standardized practice. In parallel, a national clinical protocol, MEASURE, aims to prospectively validate standardized AML MRD testing across 18 major U.S. cancer centers.

“We’ve now shown that on a national level, flow cytometry works in the real world. It’s a test worth doing. But it depends on who’s doing the test,” said Jesse Tettero, who led the study as a researcher at Virginia Tech’s Fralin Biomedical Research Institute.

“The work Tettero has done is very important to benchmark where we currently are in clinical practice, and the scale of the challenge we face if we are going to truly deliver on the promise of personalized medicine. As a physician-scientist, Tettero understands both the unmet needs of patients suffering from this terrible disease but also the incredible opportunity offered by advanced technological solutions and why translational research is so important for medical progress,” said Chris Hourigan, director of the Fralin Biomedical Research Institute’s Cancer Research Center in Washington, D.C.

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Fralin Biomedical Research Institute at VTC