I think the controversies are that it’s an outstanding biomarker if it’s able to be monitored. There are some patients who, for example, don’t have a detectable clone if we’re using NGS-based MRD methods. And so that’s a limitation. Flow-based MRD is usually informative in almost all patients, but it’s not as sensitive as the next-generation sequencing techniques...
I think the controversies are that it’s an outstanding biomarker if it’s able to be monitored. There are some patients who, for example, don’t have a detectable clone if we’re using NGS-based MRD methods. And so that’s a limitation. Flow-based MRD is usually informative in almost all patients, but it’s not as sensitive as the next-generation sequencing techniques. In addition, the NGS techniques have not yet been validated or completely approved for T-ALL. So in that setting, still the standard of care, I think, is flow-based MRD for T-ALL. I think in North America, probably in Europe as well, the standard for AML in general is NGS-based MRD detection, but that’s not always informative. It’s informative in the vast majority of cases, but you can’t always detect a clone. It’s also expensive and not universally available. I think in the early studies, there were some studies from the MD Anderson which suggested that patients with Ph-like ALL who are MRD negative still had poor outcomes. I think with NGS techniques now, if patients are truly MRD negative, we’re seeing that it’s probably quite a robust marker for a particular patient. It’s highly predictive of outcome, I think, for almost any subset of ALL, and I don’t know of one where it would not necessarily be predictive of outcome.
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