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Variable response to chemotherapy in AML represents a major treatment challenge. While clinical and genetic features incompletely predict outcome, there is a clear correlations between patient outcome in AML and DNA methylation patterns. However, tests directly measuring multiple-locus DNA methylation are expensive and technically challenging.
There is a need for a better, cheaper, and readily available diagnostic test to inform clinicians about appropriate treatment and better identify AML patients who are likely to achieve remission.
This technique is inexpensive and easily performed in a clinical molecular pathology laboratory. Inventors used xMELP to analyze methylation pattern at 18 loci in AML patients and determined methylation statistic (M-score) for 166 patients with de novo AML and in independent cohort of 383 patients from the Eastern Cooperative Oncology Group (ECOG).
M Score segregates AML patients into prognostic subgroups with significantly distinct mortality risk (P = 0.009). In the ECOG study, M-score was associated with death (P = 0.011) and failure to achieve CR (P = 0.034). Median survival was 26.6 months versus 10.6 months for low and high M-score groups. Thus, the xMELP assay and associated M-score can be used for prognosis and for clinical decision making in AML patients.