Complex clonal dynamics of AML demand coverage across more genomic regions than current digital PCR methods are able to interrogate. However, current NGS pan-heme panels lack sufficient sensitivity for reliable detection of MRD, as their limits of detection are between 1-5% mutant allele frequency (MAF).
- The AML-MRD-SEQ Panel demonstrates ultra-sensitive detection of low frequency mutations, with a calling threshold of 7 MM (0.035% MAF for 20,000 GE DNA input), with high specificity. This represents a sensitivity improvement over pan-heme NGS tests of ~50 -100 X.2,3
- AML-MRD-SEQ achieves increased, yet targeted, genomic coverage. The assay also interrogates other clinically relevant markers to evaluate the association between detection with unparalleled sensitivity and clinical outcomes.
- Refined risk classification
- More robust post-transplant surveillance
- Accelerated therapeutic development as a surrogate endpoint
Accelerate clinical development
By offering reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus pan-heme NGS tests, AML-MRD-SEQ can accelerate clinical development of novel therapeutics leading to more reliable information on which to base important decisions for AML patients.