NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend MRD testing as a Category 2A recommendation for multiple myeloma patients after each treatment stage (e.g., induction, high-dose therapy/ASCT, consolidation, maintenance) at times of suspected complete response. NCCN also recommends it for ALL
NCCN also recomemnds it under certain conditions for CLL. IN its 2026 guideline, in updates (p. 5), it says: ” Consider next generation sequencing (NGS)-based clonality testing for measurable residual disease (MRD) assessment if MRD-guided treatment is planned and MRD flow is not being used for MRD assessment. See CSLL-E”.
Clonosec is an NGS based MRD method, which NCCN accepts.
On p. CSLL-E, it says: ” Evidence from clinical trials suggests that undetectable MRD in the peripheral blood after the end of time-limited treatment is an important
predictor of efficacy.a-e
• Allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and six-color flow cytometry (MRD flow) are the two validated methods
used for the detection of MRD at the level of 10-4 to 10-5 .f,g Next-generation sequencing (NGS)-based assays have been shown to be more
sensitive, thus allowing for the detection of MRD at the level of 10-6 .h-j
• MRD evaluation should be performed using an assay with a sensitivity of 10-4 according to the standardized European Research Initiative on
CLL (ERIC) method or standardized NGS method.
• For MRD-guided treatment, serial MRD evaluations using either flow cytometry (MRD flow) or NGS with a limit of detection (sensitivity) of
at least 10-4 CLL cells in blood or bone marrow may be performed every 3 to 6 months during active treatment as directed in the published
trial results that support MRD-guided treatment regimens. See the publications for details on MRD assessments and management, including
criteria for treatment discontinuation (CSLL-E 2 of 2).
• Either flow cytometry (MRD flow) or NGS are acceptable assays as long as the limit of detection (sensitivity) is achieved.”..